AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 4NCT00563381

Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients.

A Phase 4 study testing Tiotropium bromide and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 752 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomised, double-blind, double-dummy, multinational, multicentre, parallel group trial comparing tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg) via MDI in patients with COPD. There will be a two-week run-in period followed by a 52-week randomised treatment phase. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Tiotropium bromide and Salmeterol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
7,376 participants
Where
752 sitesin 25 countries
Study dates
Jan 2008to Apr 2010
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) and must meet the following criteria at Visit 1:
  • Patients must have relatively stable, moderate to very severe airway obstruction with a post-bronchodilator FEV1 <=70% of predicted normal and FEV1 <=70% of FVC post-bronchodilator (i.e. 30 minutes after inhalation of 4 puffs of 100 µg salbutamol or equivalent SABA). Predicted normal values will be calculated according to ECSC.
  • For Height measured in inches Males: FEV1 predicted (L) = 4.30 x (height (inches) / 39.37)-0.029 x age (yrs) - 2.49 Females:FEV1 predicted (L) = 3.95 x (height (inches) / 39.37)-0.025 x age (yrs) - 2.60 For Height measured in metres Males: FEV1 predicted (L) = 4.30 x (height (metres)) - 0.029 x age (years) - 2.49 Females: FEV1 predicted (L) = 3.95 x (height (metres)) - 0.025 x age (years) - 2.60
  • All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial.
  • Male or female patients 40 years of age or older.
  • Patients with a history of at least one exacerbation within the past year requiring treatment with either antibiotics and/or systemic steroids and/or hospitalisation.
Show all 10Show fewer
  • Patients must be current or ex-smokers with a smoking history of >= 10 pack-years. (Patients who have never smoked cigarettes must be excluded.)
  • Patients must be able to perform all study-related procedures including technically acceptable pulmonary function tests (PFTs).
  • Patients must be able to inhale medication in a competent manner from the HandiHaler and a metered dose inhaler (MDI).
  • Patients must be able to maintain records (patient daily diary card) during the study period as required in the protocol.

Who cannot join

  • Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patients' ability to participate in the study.
  • Patients with a diagnosis of asthma.
  • Patients with a life-threatening pulmonary obstruction, or a history of cystic fibrosis.
  • Patients with known active tuberculosis.
  • Patients with a known symptomatic prostatic hyperplasia or bladder neck obstruction. Patients with symptomatically-controlled prostatic hyperplasia on medication may be included and should continue their medication.
  • Patients with known narrow-angle glaucoma.
Show all 22Show fewer
  • Patients with a history of myocardial infarction within the year prior to Visit 1.
  • Patients with a history of hospital admission for heart failure within the year prior to Visit 1.
  • Patients with cardiac arrhythmia requiring medical or surgical treatment.
  • Patients with severe cardiovascular disorders.
  • Patients with a known hypersensitivity to anticholinergic drugs, beta-adrenergics, lactose or any other component of the medication delivery system.
  • Patients with known moderate or severe renal insufficiency (known creatinine clearance of <= 50 mL/min).
  • Patients with untreated known hypokalaemia.
  • Patients with untreated known thyrotoxicosis.
  • Patients with brittle/unstable diabetes mellitus.
  • Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion 1.
  • Patients who have taken an investigational drug within 30 days or six half-lives (whichever is greater) prior to Screening Visit (Visit 1).
  • Use of systemic corticosteroid medication at unstable doses (i.e less than six weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone per day or 20 mg every other day.
  • Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e oral contraceptives, intrauterine devices, diaphragm or subdermal implants e.g Norplant) for at least three months prior to, and for the duration of the trial.
  • Previous participation (receipt of randomised treatment) in this study.
  • Patients who are currently participating in another study.
  • Patients with any respiratory infection or COPD exacerbation in the four weeks prior to the Screening Visit (Visit 1) or during the run-in period should be postponed. In the case of a respiratory infection or COPD exacerbation during the run-in period, the latter may be extended up to four weeks.

Trial locations and contacts

752 sites in 25 countries.

752 sites in 25 countries

Germany164 sites

  • 205.389.1741 Boehringer Ingelheim Investigational Site

    Aachen

  • 205.389.1857 Boehringer Ingelheim Investigational Site

    Aalen

  • 205.389.1934 Boehringer Ingelheim Investigational Site

    Auerbach

  • 205.389.1868 Boehringer Ingelheim Investigational Site

    Augsburg

  • 205.389.1887 Boehringer Ingelheim Investigational Site

    Augsburg

  • 205.389.1707 Boehringer Ingelheim Investigational Site

    Bad Lippspringe

  • 205.389.1722 Boehringer Ingelheim Investigational Site

    Bad Pymont

  • 205.389.1850 Boehringer Ingelheim Investigational Site

    Bad Wörishofen

  • 205.389.1765 Boehringer Ingelheim Investigational Site

    Bahrdorf

  • 205.389.1792 Boehringer Ingelheim Investigational Site

    Beckum

  • 205.389.1801 Boehringer Ingelheim Investigational Site

    Bensheim

  • 205.389.1946 Boehringer Ingelheim Investigational Site

    Bensheim

  • 205.389.1824 Boehringer Ingelheim Investigational Site

    Bergisch Gladbach

  • 205.389.1709 Boehringer Ingelheim Investigational Site

    Bergkamen

  • 205.389.1750 Boehringer Ingelheim Investigational Site

    Berkatal-Frankershausen

  • 205.389.1701 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1743 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1769 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1789 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1790 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1847 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1855 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1861 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1862 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1867 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1903 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1931 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1932 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1937 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1960 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1969 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1981 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1983 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1984 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.389.1747 Boehringer Ingelheim Investigational Site

    Bocholt

  • 205.389.1808 Boehringer Ingelheim Investigational Site

    Bochum

  • 205.389.1811 Boehringer Ingelheim Investigational Site

    Bochum

  • 205.389.1828 Boehringer Ingelheim Investigational Site

    Bonn

  • 205.389.1870 Boehringer Ingelheim Investigational Site

    Bonn

  • 205.389.1705 Boehringer Ingelheim Investigational Site

    Borna

  • 205.389.1809 Boehringer Ingelheim Investigational Site

    Brandenburg/Havel

  • 205.389.1859 Boehringer Ingelheim Investigational Site

    Bruchsal

  • 205.389.1734 Boehringer Ingelheim Investigational Site

    Camburg

  • 205.389.1923 Boehringer Ingelheim Investigational Site

    Celle

  • 205.389.1892 Boehringer Ingelheim Investigational Site

    Cologne

  • 205.389.1974 Boehringer Ingelheim Investigational Site

    Cologne

  • 205.389.1901 Boehringer Ingelheim Investigational Site

    Coswig

  • 205.389.1891 Boehringer Ingelheim Investigational Site

    Cottbus

  • 205.389.1858 Boehringer Ingelheim Investigational Site

    Deggendorf

  • 205.389.1784 Boehringer Ingelheim Investigational Site

    Donaueschingen

  • 205.389.1713 Boehringer Ingelheim Investigational Site

    Dortmund

  • 205.389.1706 Boehringer Ingelheim Investigational Site

    Dresden

  • 205.389.1967 Boehringer Ingelheim Investigational Site

    Düren

  • 205.389.1814 Boehringer Ingelheim Investigational Site

    Engelskirchen

  • 205.389.1773 Boehringer Ingelheim Investigational Site

    Ense

  • 205.389.1727 Boehringer Ingelheim Investigational Site

    Eppelborn-Bubach

  • 205.389.1864 Boehringer Ingelheim Investigational Site

    Erfurt

  • 205.389.1940 Boehringer Ingelheim Investigational Site

    Erlangen

  • 205.389.1900 Boehringer Ingelheim Investigational Site

    Eschwege

  • 205.389.1758 Boehringer Ingelheim Investigational Site

    Essen

  • 205.389.1975 Boehringer Ingelheim Investigational Site

    Essen

  • 205.389.1982 Boehringer Ingelheim Investigational Site

    Essen

  • 205.389.1724 Boehringer Ingelheim Investigational Site

    Ettlingen

  • 205.389.1806 Boehringer Ingelheim Investigational Site

    Feldkirchen-Westerham

  • 205.389.1943 Boehringer Ingelheim Investigational Site

    Föhren

  • 205.389.1976 Boehringer Ingelheim Investigational Site

    Forchheim

  • 205.389.1795 Boehringer Ingelheim Investigational Site

    Frankenberg

  • 205.389.1905 Boehringer Ingelheim Investigational Site

    Frankfurt am Main

  • 205.389.1752 Boehringer Ingelheim Investigational Site

    Fuldatal-Ihringshausen

  • 205.389.1971 Boehringer Ingelheim Investigational Site

    Fürth

  • 205.389.1766 Boehringer Ingelheim Investigational Site

    Gars

  • 205.389.1977 Boehringer Ingelheim Investigational Site

    Gelsenkirchen

  • 205.389.1744 Boehringer Ingelheim Investigational Site

    Georgensgmünd

  • 205.389.1875 Boehringer Ingelheim Investigational Site

    Giessen

  • 205.389.1836 Boehringer Ingelheim Investigational Site

    Gifhorn

  • 205.389.1914 Boehringer Ingelheim Investigational Site

    Goch

  • 205.389.1751 Boehringer Ingelheim Investigational Site

    Göttingen

  • 205.389.1886 Boehringer Ingelheim Investigational Site

    Greiz

  • 205.389.1768 Boehringer Ingelheim Investigational Site

    Grünberg

  • 205.389.1831 Boehringer Ingelheim Investigational Site

    Hagen

  • 205.389.1827 Boehringer Ingelheim Investigational Site

    Halle

  • 205.389.1917 Boehringer Ingelheim Investigational Site

    Hamburg

  • 205.389.1924 Boehringer Ingelheim Investigational Site

    Hamburg

  • 205.389.1925 Boehringer Ingelheim Investigational Site

    Hamburg

  • 205.389.1980 Boehringer Ingelheim Investigational Site

    Hamburg

  • 205.389.1716 Boehringer Ingelheim Investigational Site

    Hammah

  • 205.389.1702 Boehringer Ingelheim Investigational Site

    Hammelburg

  • 205.389.1802 Boehringer Ingelheim Investigational Site

    Hanover

  • 205.389.1712 Boehringer Ingelheim Investigational Site

    Harsewinkel

  • 205.389.1738 Boehringer Ingelheim Investigational Site

    Hauzenberg

  • 205.389.1860 Boehringer Ingelheim Investigational Site

    Hemmingen

  • 205.389.1949 Boehringer Ingelheim Investigational Site

    Höchstädt

  • 205.389.1726 Boehringer Ingelheim Investigational Site

    Ingelheim

  • 205.389.1704 Boehringer Ingelheim Investigational Site

    Käbschütztal-Krögis

  • 205.389.1873 Boehringer Ingelheim Investigational Site

    Karlsruhe

  • 205.389.1838 Boehringer Ingelheim Investigational Site

    Kaufbeuren

  • 205.389.1839 Boehringer Ingelheim Investigational Site

    Koblenz

  • 205.389.1813 Boehringer Ingelheim Investigational Site

    Köthen

  • 205.389.1881 Boehringer Ingelheim Investigational Site

    Krefeld

  • 205.389.1786 Boehringer Ingelheim Investigational Site

    Krumpa

  • 205.389.1902 Boehringer Ingelheim Investigational Site

    Landsberg

  • 205.389.1837 Boehringer Ingelheim Investigational Site

    Leipzig

  • 205.389.1841 Boehringer Ingelheim Investigational Site

    Leipzig

  • 205.389.1894 Boehringer Ingelheim Investigational Site

    Leipzig

  • 205.389.1908 Boehringer Ingelheim Investigational Site

    Leipzig

  • 205.389.1874 Boehringer Ingelheim Investigational Site

    Leonberg

  • 205.389.1955 Boehringer Ingelheim Investigational Site

    Limburg

  • 205.389.1904 Boehringer Ingelheim Investigational Site

    Lorch

  • 205.389.1877 Boehringer Ingelheim Investigational Site

    Lübeck

  • 205.389.1823 Boehringer Ingelheim Investigational Site

    Lützen

  • 205.389.1879 Boehringer Ingelheim Investigational Site

    Magdeburg

  • 205.389.1840 Boehringer Ingelheim Investigational Site

    Mannheim

  • 205.389.1978 Boehringer Ingelheim Investigational Site

    Mannheim

  • 205.389.1866 Boehringer Ingelheim Investigational Site

    Marburg

  • 205.389.1871 Boehringer Ingelheim Investigational Site

    Marburg

  • 205.389.1926 Boehringer Ingelheim Investigational Site

    Marburg

  • 205.389.1776 Boehringer Ingelheim Investigational Site

    Marl

  • 205.389.1779 Boehringer Ingelheim Investigational Site

    Merrbusch

  • 205.389.1799 Boehringer Ingelheim Investigational Site

    München

  • 205.389.1815 Boehringer Ingelheim Investigational Site

    München

  • 205.389.1817 Boehringer Ingelheim Investigational Site

    München

  • 205.389.1843 Boehringer Ingelheim Investigational Site

    München

  • 205.389.1952 Boehringer Ingelheim Investigational Site

    Neubrandenburg

  • 205.389.1805 Boehringer Ingelheim Investigational Site

    Neuötting

  • 205.389.1948 Boehringer Ingelheim Investigational Site

    Neuss

  • 205.389.1958 Boehringer Ingelheim Investigational Site

    Neuwied

  • 205.389.1830 Boehringer Ingelheim Investigational Site

    Niesky

  • 205.389.1711 Boehringer Ingelheim Investigational Site

    Nußbach

  • 205.389.1781 Boehringer Ingelheim Investigational Site

    Oberdorla

  • 205.389.1753 Boehringer Ingelheim Investigational Site

    Paderborn

  • 205.389.1810 Boehringer Ingelheim Investigational Site

    Paderborn

  • 205.389.1854 Boehringer Ingelheim Investigational Site

    Paderborn

  • 205.389.1756 Boehringer Ingelheim Investigational Site

    Pirmasens

  • 205.389.1794 Boehringer Ingelheim Investigational Site

    Potsdam

  • 205.389.1899 Boehringer Ingelheim Investigational Site

    Potsdam

  • 205.389.1842 Boehringer Ingelheim Investigational Site

    Radebeul

  • 205.389.1897 Boehringer Ingelheim Investigational Site

    Rathenow

  • 205.389.1950 Boehringer Ingelheim Investigational Site

    Raubach

  • 205.389.1783 Boehringer Ingelheim Investigational Site

    Riesa

  • 205.389.1826 Boehringer Ingelheim Investigational Site

    Riesa

  • 205.389.1742 Boehringer Ingelheim Investigational Site

    Rostock

  • 205.389.1816 Boehringer Ingelheim Investigational Site

    Rüdersdorf

  • 205.389.1883 Boehringer Ingelheim Investigational Site

    Rüsselsheim am Main

  • 205.389.1878 Boehringer Ingelheim Investigational Site

    Saarlouis

  • 205.389.1833 Boehringer Ingelheim Investigational Site

    Schmallenberg-Grafschaft

  • 205.389.1973 Boehringer Ingelheim Investigational Site

    Schmölln

  • 205.389.1979 Boehringer Ingelheim Investigational Site

    Schwetzingen

  • 205.389.1856 Boehringer Ingelheim Investigational Site

    Simmern

  • 205.389.1918 Boehringer Ingelheim Investigational Site

    Solingen

  • 205.389.1822 Boehringer Ingelheim Investigational Site

    Steinfurt

  • 205.389.1728 Boehringer Ingelheim Investigational Site

    Sulzbach

  • 205.389.1717 Boehringer Ingelheim Investigational Site

    Templin

  • 205.389.1882 Boehringer Ingelheim Investigational Site

    Treuenbrietzen

  • 205.389.1745 Boehringer Ingelheim Investigational Site

    Wallerfing

  • 205.389.1800 Boehringer Ingelheim Investigational Site

    Wardenburg

  • 205.389.1885 Boehringer Ingelheim Investigational Site

    Weißenhorn

  • 205.389.1927 Boehringer Ingelheim Investigational Site

    Westerstede

  • 205.389.1825 Boehringer Ingelheim Investigational Site

    Weyhe

  • 205.389.1863 Boehringer Ingelheim Investigational Site

    Wiesbaden

  • 205.389.1968 Boehringer Ingelheim Investigational Site

    Wilhelmshaven

  • 205.389.1807 Boehringer Ingelheim Investigational Site

    Wilster

  • 205.389.1754 Boehringer Ingelheim Investigational Site

    Wolfsburg

  • 205.389.1919 Boehringer Ingelheim Investigational Site

    Wuppertal

  • 205.389.1898 Boehringer Ingelheim Investigational Site

    Zerbst

Other trials in Germany

Poland93 sites

  • 205.389.2708 Boehringer Ingelheim Investigational Site

    Bialystok

  • 205.389.2744 Boehringer Ingelheim Investigational Site

    Bialystok

  • 205.389.2762 Boehringer Ingelheim Investigational Site

    Bialystok

  • 205.389.2765 Boehringer Ingelheim Investigational Site

    Bialystok

  • 205.389.2778 Boehringer Ingelheim Investigational Site

    Bielsko-Biala

  • 205.389.2706 Boehringer Ingelheim Investigational Site

    Bieńkówka

  • 205.389.2750 Boehringer Ingelheim Investigational Site

    Brzesko

  • 205.389.2758 Boehringer Ingelheim Investigational Site

    Bydgoszcz

  • 205.389.2773 Boehringer Ingelheim Investigational Site

    Bystra

  • 205.389.2800 Boehringer Ingelheim Investigational Site

    Chodzież

  • 205.389.2712 Boehringer Ingelheim Investigational Site

    Częstochowa

  • 205.389.2774 Boehringer Ingelheim Investigational Site

    Częstochowa

  • 205.389.2815 Boehringer Ingelheim Investigational Site

    Działdowo

  • 205.389.2787 Boehringer Ingelheim Investigational Site

    Elblag

  • 205.389.2715 Boehringer Ingelheim Investigational Site

    Gdansk

  • 205.389.2723 Boehringer Ingelheim Investigational Site

    Gdansk

  • 205.389.2743 Boehringer Ingelheim Investigational Site

    Gdansk

  • 205.389.2764 Boehringer Ingelheim Investigational Site

    Gdansk

  • 205.389.2802 Boehringer Ingelheim Investigational Site

    Gdansk

  • 205.389.2801 Boehringer Ingelheim Investigational Site

    Gorzow Wlkp

  • 205.389.2805 Boehringer Ingelheim Investigational Site

    Iława

  • 205.389.2791 Boehringer Ingelheim Investigational Site

    Inowrocław

  • 205.389.2705 Boehringer Ingelheim Investigational Site

    Katowice

  • 205.389.2749 Boehringer Ingelheim Investigational Site

    Katowice

  • 205.389.2771 Boehringer Ingelheim Investigational Site

    Katowice

  • 205.389.2759 Boehringer Ingelheim Investigational Site

    Koszalin

  • 205.389.2711 Boehringer Ingelheim Investigational Site

    Krakow

  • 205.389.2722 Boehringer Ingelheim Investigational Site

    Krakow

  • 205.389.2747 Boehringer Ingelheim Investigational Site

    Krakow

  • 205.389.2748 Boehringer Ingelheim Investigational Site

    Krakow

  • 205.389.2753 Boehringer Ingelheim Investigational Site

    Krakow

  • 205.389.2798 Boehringer Ingelheim Investigational Site

    Krakow

  • 205.389.2757 Boehringer Ingelheim Investigational Site

    Kutno

  • 205.389.2727 Boehringer Ingelheim Investigational Site

    Leszno

  • 205.389.2701 Boehringer Ingelheim Investigational Site

    Lodz

  • 205.389.2709 Boehringer Ingelheim Investigational Site

    Lodz

  • 205.389.2716 Boehringer Ingelheim Investigational Site

    Lodz

  • 205.389.2724 Boehringer Ingelheim Investigational Site

    Lodz

  • 205.389.2732 Boehringer Ingelheim Investigational Site

    Lodz

  • 205.389.2746 Boehringer Ingelheim Investigational Site

    Lodz

  • 205.389.2751 Boehringer Ingelheim Investigational Site

    Lodz

  • 205.389.2804 Boehringer Ingelheim Investigational Site

    Łomża

  • 205.389.2741 Boehringer Ingelheim Investigational Site

    Lublin

  • 205.389.2776 Boehringer Ingelheim Investigational Site

    Lublin

  • 205.389.2817 Boehringer Ingelheim Investigational Site

    Lublin

  • 205.389.2760 Boehringer Ingelheim Investigational Site

    Oława

  • 205.389.2756 Boehringer Ingelheim Investigational Site

    Olsztyn

  • 205.389.2816 Boehringer Ingelheim Investigational Site

    Olsztyn

  • 205.389.2702 Boehringer Ingelheim Investigational Site

    Ostrow Wielkopolska

  • 205.389.2726 Boehringer Ingelheim Investigational Site

    Pabianice

  • 205.389.2795 Boehringer Ingelheim Investigational Site

    Pławno

  • 205.389.2730 Boehringer Ingelheim Investigational Site

    Płock

  • 205.389.2703 Boehringer Ingelheim Investigational Site

    Poznan

  • 205.389.2719 Boehringer Ingelheim Investigational Site

    Poznan

  • 205.389.2737 Boehringer Ingelheim Investigational Site

    Poznan

  • 205.389.2766 Boehringer Ingelheim Investigational Site

    Poznan

  • 205.389.2769 Boehringer Ingelheim Investigational Site

    Poznan

  • 205.389.2813 Boehringer Ingelheim Investigational Site

    Poznan

  • 205.389.2763 Boehringer Ingelheim Investigational Site

    Proszowice

  • 205.389.2767 Boehringer Ingelheim Investigational Site

    Pruszków

  • 205.389.2768 Boehringer Ingelheim Investigational Site

    Radom

  • 205.389.2792 Boehringer Ingelheim Investigational Site

    Sandomierz

  • 205.389.2781 Boehringer Ingelheim Investigational Site

    Sieradz

  • 205.389.2725 Boehringer Ingelheim Investigational Site

    Skierniewice

  • 205.389.2718 Boehringer Ingelheim Investigational Site

    Szczecin

  • 205.389.2739 Boehringer Ingelheim Investigational Site

    Szczecin

  • 205.389.2772 Boehringer Ingelheim Investigational Site

    Szczecin

  • 205.389.2777 Boehringer Ingelheim Investigational Site

    Szczecin - Zdunowo

  • 205.389.2782 Boehringer Ingelheim Investigational Site

    Szczecin - Zdunowo

  • 205.389.2738 Boehringer Ingelheim Investigational Site

    Tarnów

  • 205.389.2799 Boehringer Ingelheim Investigational Site

    Tarnów

  • 205.389.2810 Boehringer Ingelheim Investigational Site

    Tczew

  • 205.389.2775 Boehringer Ingelheim Investigational Site

    Torun

  • 205.389.2754 Boehringer Ingelheim Investigational Site

    Tranow

  • 205.389.2806 Boehringer Ingelheim Investigational Site

    Turek

  • 205.389.2803 Boehringer Ingelheim Investigational Site

    Wabrzenzo

  • 205.389.2707 Boehringer Ingelheim Investigational Site

    Warsaw

  • 205.389.2714 Boehringer Ingelheim Investigational Site

    Warsaw

  • 205.389.2728 Boehringer Ingelheim Investigational Site

    Warsaw

  • 205.389.2734 Boehringer Ingelheim Investigational Site

    Warsaw

  • 205.389.2812 Boehringer Ingelheim Investigational Site

    Warsaw

  • 205.389.2818 Boehringer Ingelheim Investigational Site

    Warsaw

  • 205.389.2710 Boehringer Ingelheim Investigational Site

    Wodzisław Śląski

  • 205.389.2721 Boehringer Ingelheim Investigational Site

    Wroclaw

  • 205.389.2731 Boehringer Ingelheim Investigational Site

    Wroclaw

  • 205.389.2736 Boehringer Ingelheim Investigational Site

    Wroclaw

  • 205.389.2752 Boehringer Ingelheim Investigational Site

    Wroclaw

  • 205.389.2761 Boehringer Ingelheim Investigational Site

    Wroclaw

  • 205.389.2780 Boehringer Ingelheim Investigational Site

    Wroclaw

  • 205.389.2793 Boehringer Ingelheim Investigational Site

    Wroclaw

  • 205.389.2783 Boehringer Ingelheim Investigational Site

    Zabrze

  • 205.389.2735 Boehringer Ingelheim Investigational Site

    Zakopane

  • 205.389.2770 Boehringer Ingelheim Investigational Site

    Zgierz

Other trials in Poland

Russia92 sites

  • 205.389.3174 Boehringer Ingelheim Investigational Site

    Arkhangelsk

  • 205.389.3113 Boehringer Ingelheim Investigational Site

    Barnaul

  • 205.389.3131 Boehringer Ingelheim Investigational Site

    Barnaul

  • 205.389.3105 Boehringer Ingelheim Investigational Site

    Chelyabinsk

  • 205.389.3182 Boehringer Ingelheim Investigational Site

    Chelyabinsk

  • 205.389.3183 Boehringer Ingelheim Investigational Site

    Chelyabinsk

  • 205.389.3184 Boehringer Ingelheim Investigational Site

    Chelyabinsk

  • 205.389.3186 Boehringer Ingelheim Investigational Site

    Gatchina (Leningradskaya Oblast)

  • 205.389.3193 Boehringer Ingelheim Investigational Site

    Kaliningrad

  • 205.389.3104 Boehringer Ingelheim Investigational Site

    Kazan'

  • 205.389.3111 Boehringer Ingelheim Investigational Site

    Kemerovo

  • 205.389.3120 Boehringer Ingelheim Investigational Site

    Kirov

  • 205.389.3170 Boehringer Ingelheim Investigational Site

    Krasnodar

  • 205.389.3132 Boehringer Ingelheim Investigational Site

    Krasnoyarsk

  • 205.389.3103 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3106 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3107 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3108 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3109 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3125 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3127 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3128 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3130 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3134 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3136 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3139 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3140 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3143 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3149 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3151 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3156 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3157 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3163 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3164 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3167 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3168 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3171 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3196 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.389.3188 Boehringer Ingelheim Investigational Site

    Murmansk

  • 205.389.3169 Boehringer Ingelheim Investigational Site

    Nizhny Novgorod

  • 205.389.3953 Boehringer Ingelheim Investigational Site

    Nizhny Novgorod

  • 205.389.3112 Boehringer Ingelheim Investigational Site

    Novosibirsk

  • 205.389.3114 Boehringer Ingelheim Investigational Site

    Novosibirsk

  • 205.389.3129 Boehringer Ingelheim Investigational Site

    Novosibirsk

  • 205.389.3141 Boehringer Ingelheim Investigational Site

    Novosibirsk

  • 205.389.3153 Boehringer Ingelheim Investigational Site

    Novosibirsk

  • 205.389.3175 Boehringer Ingelheim Investigational Site

    Novosibirsk

  • 205.389.3126 Boehringer Ingelheim Investigational Site

    Orenburg

  • 205.389.3185 Boehringer Ingelheim Investigational Site

    Perm

  • 205.389.3192 Boehringer Ingelheim Investigational Site

    Petrozavodsk

  • 205.389.3179 Boehringer Ingelheim Investigational Site

    Pskov

  • 205.389.3190 Boehringer Ingelheim Investigational Site

    Pskov

  • 205.389.3199 Boehringer Ingelheim Investigational Site

    Pyatigorsk

  • 205.389.3159 Boehringer Ingelheim Investigational Site

    Rostov-on-Don

  • 205.389.3197 Boehringer Ingelheim Investigational Site

    Ryazan

  • 205.389.3117 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3119 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3121 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3122 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3123 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3135 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3137 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3145 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3146 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3147 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3152 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3160 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3161 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3176 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3177 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3178 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3180 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3181 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3189 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3191 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3195 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3198 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3950 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 205.389.3110 Boehringer Ingelheim Investigational Site

    Saratov

  • 205.389.3951 Boehringer Ingelheim Investigational Site

    Saratov

  • 205.389.3165 Boehringer Ingelheim Investigational Site

    St.Peterburg

  • 205.389.3101 Boehringer Ingelheim Investigational Site

    Tomsk

  • 205.389.3102 Boehringer Ingelheim Investigational Site

    Tomsk

  • 205.389.3133 Boehringer Ingelheim Investigational Site

    Tomsk

  • 205.389.3144 Boehringer Ingelheim Investigational Site

    Tomsk

  • 205.389.3194 Boehringer Ingelheim Investigational Site

    Velikiy Novgorod

  • 205.389.3118 Boehringer Ingelheim Investigational Site

    Yaroslavl

  • 205.389.3155 Boehringer Ingelheim Investigational Site

    Yaroslavl

  • 205.389.3116 Boehringer Ingelheim Investigational Site

    Yekaterinburg

  • 205.389.3138 Boehringer Ingelheim Investigational Site

    Yekaterinburg

  • 205.389.3148 Boehringer Ingelheim Investigational Site

    Yekaterinburg

  • 205.389.3166 Boehringer Ingelheim Investigational Site

    Yekaterinburg

Other trials in Russia

Ukraine52 sites

  • 205.389.3521 Boehringer Ingelheim Investigational Site

    AR Crimea

  • 205.389.3516 Boehringer Ingelheim Investigational Site

    Cherkassy

  • 205.389.3549 Boehringer Ingelheim Investigational Site

    Chernivtsi

  • 205.389.3509 Boehringer Ingelheim Investigational Site

    Dnipropetrovsk

  • 205.389.3510 Boehringer Ingelheim Investigational Site

    Dnipropetrovsk

  • 205.389.3511 Boehringer Ingelheim Investigational Site

    Dnipropetrovsk

  • 205.389.3523 Boehringer Ingelheim Investigational Site

    Dnipropetrovsk

  • 205.389.3514 Boehringer Ingelheim Investigational Site

    Donetsk

  • 205.389.3524 Boehringer Ingelheim Investigational Site

    Donetsk

  • 205.389.3533 Boehringer Ingelheim Investigational Site

    Ivano-Frankivsk

  • 205.389.3506 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 205.389.3507 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 205.389.3508 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 205.389.3520 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 205.389.3522 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 205.389.3532 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 205.389.3539 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 205.389.3541 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 205.389.3543 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 205.389.3555 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 205.389.3501 Boehringer Ingelheim Investigational Site

    Kiev

  • 205.389.3502 Boehringer Ingelheim Investigational Site

    Kiev

  • 205.389.3503 Boehringer Ingelheim Investigational Site

    Kiev

  • 205.389.3550 Boehringer Ingelheim Investigational Site

    Kiev

  • 205.389.3552 Boehringer Ingelheim Investigational Site

    Kiev

  • 205.389.3553 Boehringer Ingelheim Investigational Site

    Kiev

  • 205.389.3504 Boehringer Ingelheim Investigational Site

    Kyiv

  • 205.389.3525 Boehringer Ingelheim Investigational Site

    Kyiv

  • 205.389.3526 Boehringer Ingelheim Investigational Site

    Kyiv

  • 205.389.3528 Boehringer Ingelheim Investigational Site

    Kyiv

  • 205.389.3534 Boehringer Ingelheim Investigational Site

    Kyiv

  • 205.389.3535 Boehringer Ingelheim Investigational Site

    Kyiv

  • 205.389.3536 Boehringer Ingelheim Investigational Site

    Kyiv

  • 205.389.3538 Boehringer Ingelheim Investigational Site

    Kyiv

  • 205.389.3551 Boehringer Ingelheim Investigational Site

    Kyiv

  • 205.389.3545 Boehringer Ingelheim Investigational Site

    Luhansk

  • 205.389.3512 Boehringer Ingelheim Investigational Site

    Lviv

  • 205.389.3530 Boehringer Ingelheim Investigational Site

    Lviv

  • 205.389.3540 Boehringer Ingelheim Investigational Site

    Lviv

  • 205.389.3554 Boehringer Ingelheim Investigational Site

    Lviv

  • 205.389.3556 Boehringer Ingelheim Investigational Site

    m.Donetsk

  • 205.389.3513 Boehringer Ingelheim Investigational Site

    m.Odesa

  • 205.389.3519 Boehringer Ingelheim Investigational Site

    Odesa

  • 205.389.3527 Boehringer Ingelheim Investigational Site

    Odesa

  • 205.389.3542 Boehringer Ingelheim Investigational Site

    Odesa

  • 205.389.3531 Boehringer Ingelheim Investigational Site

    Poltava

  • 205.389.3517 Boehringer Ingelheim Investigational Site

    Simferopil

  • 205.389.3518 Boehringer Ingelheim Investigational Site

    Ternopil

  • 205.389.3529 Boehringer Ingelheim Investigational Site

    Vinnitsa

  • 205.389.3515 Boehringer Ingelheim Investigational Site

    Zaporizhzhya

  • 205.389.3547 Boehringer Ingelheim Investigational Site

    Zaporizhzhya

  • 205.389.3548 Boehringer Ingelheim Investigational Site

    Zaporizhzhya

Other trials in Ukraine

France50 sites

  • 205.389.1607 Boehringer Ingelheim Investigational Site

    Baugé

  • 205.389.1525 Boehringer Ingelheim Investigational Site

    Beauvais

  • 205.389.1523 Boehringer Ingelheim Investigational Site

    Béthune

  • 205.389.1571 Boehringer Ingelheim Investigational Site

    Cestas

  • 205.389.1561 Boehringer Ingelheim Investigational Site

    Charry Le Rouet

  • 205.389.1507 Boehringer Ingelheim Investigational Site

    Cholet

  • 205.389.1606 Boehringer Ingelheim Investigational Site

    Écouflant

  • 205.389.1554 Boehringer Ingelheim Investigational Site

    Ermont

  • 205.389.1597 Boehringer Ingelheim Investigational Site

    La Barre-de-Monts

  • 205.389.1581 Boehringer Ingelheim Investigational Site

    La Jubaudière

  • 205.389.1536 Boehringer Ingelheim Investigational Site

    La Roche-sur-Yon

  • 205.389.1598 Boehringer Ingelheim Investigational Site

    La Roche-sur-Yon

  • 205.389.1501 Boehringer Ingelheim Investigational Site

    Le Kremlin-Bicêtre

  • 205.389.1503 Boehringer Ingelheim Investigational Site

    Le Mans

  • 205.389.1586 Boehringer Ingelheim Investigational Site

    Le Pradet

  • 205.389.1528 Boehringer Ingelheim Investigational Site

    Marseille

  • 205.389.1530 Boehringer Ingelheim Investigational Site

    Marseille

  • 205.389.1558 Boehringer Ingelheim Investigational Site

    Marseille

  • 205.389.1564 Boehringer Ingelheim Investigational Site

    Marseille

  • 205.389.1565 Boehringer Ingelheim Investigational Site

    Marseille

  • 205.389.1539 Boehringer Ingelheim Investigational Site

    Montfermeil

  • 205.389.1608 Boehringer Ingelheim Investigational Site

    Nantes

  • 205.389.1526 Boehringer Ingelheim Investigational Site

    Nice

  • 205.389.1504 Boehringer Ingelheim Investigational Site

    Nîmes

  • 205.389.1502 Boehringer Ingelheim Investigational Site

    Ollioules

  • 205.389.1541 Boehringer Ingelheim Investigational Site

    Orléans

  • 205.389.1527 Boehringer Ingelheim Investigational Site

    Perpignan

  • 205.389.1532 Boehringer Ingelheim Investigational Site

    Pierre Benite Cédex

  • 205.389.1553 Boehringer Ingelheim Investigational Site

    Rennes

  • 205.389.1567 Boehringer Ingelheim Investigational Site

    Saint Orens de Cameville

  • 205.389.1555 Boehringer Ingelheim Investigational Site

    Saint-Dié

  • 205.389.1514 Boehringer Ingelheim Investigational Site

    Saint-Etienne

  • 205.389.1575 Boehringer Ingelheim Investigational Site

    Saint-Germain-du-Puch

  • 205.389.1572 Boehringer Ingelheim Investigational Site

    Saint-Laurent

  • 205.389.1547 Boehringer Ingelheim Investigational Site

    Saint-Laurent-du-Var

  • 205.389.1577 Boehringer Ingelheim Investigational Site

    Saint-Pierre-Montlimart

  • 205.389.1531 Boehringer Ingelheim Investigational Site

    Saint-Quentin

  • 205.389.1520 Boehringer Ingelheim Investigational Site

    Sélestat

  • 205.389.1569 Boehringer Ingelheim Investigational Site

    Seysses

  • 205.389.1510 Boehringer Ingelheim Investigational Site

    Strasbourg

  • 205.389.1522 Boehringer Ingelheim Investigational Site

    Strasbourg

  • 205.389.1512 Boehringer Ingelheim Investigational Site

    Toulon

  • 205.389.1515 Boehringer Ingelheim Investigational Site

    Toulon

  • 205.389.1519 Boehringer Ingelheim Investigational Site

    Toulon

  • 205.389.1588 Boehringer Ingelheim Investigational Site

    Toulon

  • 205.389.1589 Boehringer Ingelheim Investigational Site

    Toulon

  • 205.389.1590 Boehringer Ingelheim Investigational Site

    Toulon

  • 205.389.1595 Boehringer Ingelheim Investigational Site

    Toulon

  • 205.389.1542 Boehringer Ingelheim Investigational Site

    Toulouse

  • 205.389.1574 Boehringer Ingelheim Investigational Site

    Villenave-d'Ornon

Other trials in France

Czechia29 sites

  • 205.389.1211 Boehringer Ingelheim Investigational Site

    Benešov

  • 205.389.1213 Boehringer Ingelheim Investigational Site

    Beroun

  • 205.389.1220 Boehringer Ingelheim Investigational Site

    Beroun

  • 205.389.1204 Boehringer Ingelheim Investigational Site

    Brno-Královo Pole

  • 205.389.1212 Boehringer Ingelheim Investigational Site

    Cheb

  • 205.389.1205 Boehringer Ingelheim Investigational Site

    Havlíčkův Brod

  • 205.389.1230 Boehringer Ingelheim Investigational Site

    Humpolec

  • 205.389.1208 Boehringer Ingelheim Investigational Site

    Jaroměř

  • 205.389.1219 Boehringer Ingelheim Investigational Site

    Kyjov

  • 205.389.1225 Boehringer Ingelheim Investigational Site

    Liberec

  • 205.389.1218 Boehringer Ingelheim Investigational Site

    Litoměřice

  • 205.389.1214 Boehringer Ingelheim Investigational Site

    Lovosice

  • 205.389.1207 Boehringer Ingelheim Investigational Site

    Neratovice

  • 205.389.1222 Boehringer Ingelheim Investigational Site

    Ostrava

  • 205.389.1209 Boehringer Ingelheim Investigational Site

    Pilsen

  • 205.389.1216 Boehringer Ingelheim Investigational Site

    Pilsen

  • 205.389.1215 Boehringer Ingelheim Investigational Site

    Prague

  • 205.389.1217 Boehringer Ingelheim Investigational Site

    Prague

  • 205.389.1223 Boehringer Ingelheim Investigational Site

    Prague

  • 205.389.1227 Boehringer Ingelheim Investigational Site

    Prague

  • 205.389.1229 Boehringer Ingelheim Investigational Site

    Prague

  • 205.389.1232 Boehringer Ingelheim Investigational Site

    Prague

  • 205.389.1224 Boehringer Ingelheim Investigational Site

    Praha 6 - Brevnov

  • 205.389.1228 Boehringer Ingelheim Investigational Site

    Přerov

  • 205.389.1231 Boehringer Ingelheim Investigational Site

    Rokycany

  • 205.389.1221 Boehringer Ingelheim Investigational Site

    Strakonice

  • 205.389.1206 Boehringer Ingelheim Investigational Site

    Třemošná

  • 205.389.1201 Boehringer Ingelheim Investigational Site

    Žatec

  • 205.389.1210 Boehringer Ingelheim Investigational Site

    Znojmo

Other trials in Czechia

Hungary29 sites

  • 205.389.2001 Boehringer Ingelheim Investigational Site

    Budapest

  • 205.389.2005 Boehringer Ingelheim Investigational Site

    Budapest

  • 205.389.2006 Boehringer Ingelheim Investigational Site

    Budapest

  • 205.389.2009 Boehringer Ingelheim Investigational Site

    Budapest

  • 205.389.2016 Boehringer Ingelheim Investigational Site

    Budapest

  • 205.389.2018 Boehringer Ingelheim Investigational Site

    Budapest

  • 205.389.2027 Boehringer Ingelheim Investigational Site

    Budapest

  • 205.389.2007 Boehringer Ingelheim Investigational Site

    Debrecen

  • 205.389.2035 Boehringer Ingelheim Investigational Site

    Deszk

  • 205.389.2015 Boehringer Ingelheim Investigational Site

    Dunaújváros

  • 205.389.2008 Boehringer Ingelheim Investigational Site

    Érd

  • 205.389.2011 Boehringer Ingelheim Investigational Site

    Füzesabony

  • 205.389.2013 Boehringer Ingelheim Investigational Site

    Győr

  • 205.389.2028 Boehringer Ingelheim Investigational Site

    Gyula

  • 205.389.2014 Boehringer Ingelheim Investigational Site

    Jászberény

  • 205.389.2021 Boehringer Ingelheim Investigational Site

    Kecskemét

  • 205.389.2025 Boehringer Ingelheim Investigational Site

    Komárom

  • 205.389.2024 Boehringer Ingelheim Investigational Site

    Mosdós

  • 205.389.2026 Boehringer Ingelheim Investigational Site

    Mosonmagyaróvár

  • 205.389.2031 Boehringer Ingelheim Investigational Site

    Nyíregyháza

  • 205.389.2002 Boehringer Ingelheim Investigational Site

    Pécs

  • 205.389.2017 Boehringer Ingelheim Investigational Site

    Ráckeve

  • 205.389.2003 Boehringer Ingelheim Investigational Site

    Siófok

  • 205.389.2010 Boehringer Ingelheim Investigational Site

    Szarvas

  • 205.389.2022 Boehringer Ingelheim Investigational Site

    Százhalombatta

  • 205.389.2019 Boehringer Ingelheim Investigational Site

    Szentendre

  • 205.389.2030 Boehringer Ingelheim Investigational Site

    Tatabánya

  • 205.389.2029 Boehringer Ingelheim Investigational Site

    Törökbálint

  • 205.389.2020 Boehringer Ingelheim Investigational Site

    Veszprém

Other trials in Hungary

United Kingdom26 sites

  • 205.389.3601 Boehringer Ingelheim Investigational Site

    Bath

  • 205.389.3630 Boehringer Ingelheim Investigational Site

    Bexhill-on-Sea

  • 205.389.3636 Boehringer Ingelheim Investigational Site

    Bexhill-on-Sea

  • 205.389.3608 Boehringer Ingelheim Investigational Site

    Birmingham

  • 205.389.3605 Boehringer Ingelheim Investigational Site

    Blackburn

  • 205.389.3609 Boehringer Ingelheim Investigational Site

    Bolton

  • 205.389.3640 Boehringer Ingelheim Investigational Site

    Burbage

  • 205.389.3643 Boehringer Ingelheim Investigational Site

    Chesterfield

  • 205.389.3627 Boehringer Ingelheim Investigational Site

    Corsham

  • 205.389.3606 Boehringer Ingelheim Investigational Site

    Coventry

  • 205.389.3633 Boehringer Ingelheim Investigational Site

    Coventry

  • 205.389.3639 Boehringer Ingelheim Investigational Site

    Frome

  • 205.389.3602 Boehringer Ingelheim Investigational Site

    Glasgow

  • 205.389.3632 Boehringer Ingelheim Investigational Site

    Irvine

  • 205.389.3623 Boehringer Ingelheim Investigational Site

    London

  • 205.389.3638 Boehringer Ingelheim Investigational Site

    Middlesex

  • 205.389.3616 Boehringer Ingelheim Investigational Site

    Newcastle upon Tyne

  • 205.389.3618 Boehringer Ingelheim Investigational Site

    Paisley

  • 205.389.3622 Boehringer Ingelheim Investigational Site

    Radstock

  • 205.389.3626 Boehringer Ingelheim Investigational Site

    Randalstown

  • 205.389.3613 Boehringer Ingelheim Investigational Site

    Saint Just, Penzance

  • 205.389.3604 Boehringer Ingelheim Investigational Site

    Soham

  • 205.389.3624 Boehringer Ingelheim Investigational Site

    Sunderland

  • 205.389.3635 Boehringer Ingelheim Investigational Site

    Wansford, Peterborough

  • 205.389.3631 Boehringer Ingelheim Investigational Site

    Windsor

  • 205.389.3612 Boehringer Ingelheim Investigational Site

    Wrexham

Other trials in United Kingdom

Spain24 sites

  • 205.389.3410 Boehringer Ingelheim Investigational Site

    Badajoz

  • 205.389.3403 Boehringer Ingelheim Investigational Site

    Badalona (Barcelona)

  • 205.389.3401 Boehringer Ingelheim Investigational Site

    Barcelona

  • 205.389.3402 Boehringer Ingelheim Investigational Site

    Barcelona

  • 205.389.3428 Boehringer Ingelheim Investigational Site

    Barcelona

  • 205.389.3416 Boehringer Ingelheim Investigational Site

    Cáceres

  • 205.389.3430 Boehringer Ingelheim Investigational Site

    Cartagena

  • 205.389.3425 Boehringer Ingelheim Investigational Site

    Elche

  • 205.389.3408 Boehringer Ingelheim Investigational Site

    Las Palmas de Gran Canarias

  • 205.389.3405 Boehringer Ingelheim Investigational Site

    Lleida

  • 205.389.3404 Boehringer Ingelheim Investigational Site

    Madrid

  • 205.389.3406 Boehringer Ingelheim Investigational Site

    Madrid

  • 205.389.3414 Boehringer Ingelheim Investigational Site

    Málaga

  • 205.389.3431 Boehringer Ingelheim Investigational Site

    Pontevedra

  • 205.389.3419 Boehringer Ingelheim Investigational Site

    Requena

  • 205.389.3427 Boehringer Ingelheim Investigational Site

    Reus

  • 205.389.3422 Boehringer Ingelheim Investigational Site

    Sagunto

  • 205.389.3420 Boehringer Ingelheim Investigational Site

    San Juan

  • 205.389.3415 Boehringer Ingelheim Investigational Site

    Santander

  • 205.389.3421 Boehringer Ingelheim Investigational Site

    Santiago de Compostela

  • 205.389.3407 Boehringer Ingelheim Investigational Site

    Terrasa (Barcelona)

  • 205.389.3413 Boehringer Ingelheim Investigational Site

    Valencia

  • 205.389.3426 Boehringer Ingelheim Investigational Site

    Valencia

  • 205.389.3417 Boehringer Ingelheim Investigational Site

    Valladolid

Other trials in Spain

Romania21 sites

  • 205.389.3009 Boehringer Ingelheim Investigational Site

    Brasov

  • 205.389.3018 Boehringer Ingelheim Investigational Site

    Brasov

  • 205.389.3023 Boehringer Ingelheim Investigational Site

    Brasov

  • 205.389.3001 Boehringer Ingelheim Investigational Site

    Bucharest

  • 205.389.3002 Boehringer Ingelheim Investigational Site

    Bucharest

  • 205.389.3004 Boehringer Ingelheim Investigational Site

    Bucharest

  • 205.389.3006 Boehringer Ingelheim Investigational Site

    Bucharest

  • 205.389.3007 Boehringer Ingelheim Investigational Site

    Bucharest

  • 205.389.3012 Boehringer Ingelheim Investigational Site

    Bucharest

  • 205.389.3013 Boehringer Ingelheim Investigational Site

    Bucharest

  • 205.389.3025 Boehringer Ingelheim Investigational Site

    Bucharest

  • 205.389.3016 Boehringer Ingelheim Investigational Site

    Constanța

  • 205.389.3019 Boehringer Ingelheim Investigational Site

    Constanța

  • 205.389.3015 Boehringer Ingelheim Investigational Site

    Craiova

  • 205.389.3008 Boehringer Ingelheim Investigational Site

    Iași

  • 205.389.3014 Boehringer Ingelheim Investigational Site

    Iași

  • 205.389.3022 Boehringer Ingelheim Investigational Site

    Iași

  • 205.389.3024 Boehringer Ingelheim Investigational Site

    Iași

  • 205.389.3005 Boehringer Ingelheim Investigational Site

    Oradea

  • 205.389.3017 Boehringer Ingelheim Investigational Site

    Tg. Mures

  • 205.389.3021 Boehringer Ingelheim Investigational Site

    Timișoara

Other trials in Romania

Austria18 sites

  • 205.389.1020 Boehringer Ingelheim Investigational Site

    Feldbach

  • 205.389.1010 Boehringer Ingelheim Investigational Site

    Feldkirch

  • 205.389.1003 Boehringer Ingelheim Investigational Site

    Gänserndorf

  • 205.389.1011 Boehringer Ingelheim Investigational Site

    Grimmenstein/Hochegg

  • 205.389.1005 Boehringer Ingelheim Investigational Site

    Hallein

  • 205.389.1023 Boehringer Ingelheim Investigational Site

    Linz

  • 205.389.1001 Boehringer Ingelheim Investigational Site

    Mittersill

  • 205.389.1027 Boehringer Ingelheim Investigational Site

    Salzburg

  • 205.389.1026 Boehringer Ingelheim Investigational Site

    Schlüsslberg

  • 205.389.1016 Boehringer Ingelheim Investigational Site

    Spittal/Drau

  • 205.389.1022 Boehringer Ingelheim Investigational Site

    Steyr

  • 205.389.1002 Boehringer Ingelheim Investigational Site

    Vienna

  • 205.389.1006 Boehringer Ingelheim Investigational Site

    Vienna

  • 205.389.1014 Boehringer Ingelheim Investigational Site

    Vienna

  • 205.389.1018 Boehringer Ingelheim Investigational Site

    Vienna

  • 205.389.1021 Boehringer Ingelheim Investigational Site

    Vienna

  • 205.389.1029 Boehringer Ingelheim Investigational Site

    Vienna

  • 205.389.1017 Boehringer Ingelheim Investigational Site

    Zwettl Stadt

Other trials in Austria

Italy18 sites

  • 205.389.2211 Boehringer Ingelheim Investigational Site

    Brescia

  • 205.389.2206 Boehringer Ingelheim Investigational Site

    Cagliari

  • 205.389.2223 Boehringer Ingelheim Investigational Site

    Catania

  • 205.389.2209 Boehringer Ingelheim Investigational Site

    Ferrara

  • 205.389.2214 Boehringer Ingelheim Investigational Site

    Genova

  • 205.389.2215 Boehringer Ingelheim Investigational Site

    Lecco

  • 205.389.2221 Boehringer Ingelheim Investigational Site

    Milan

  • 205.389.2226 Boehringer Ingelheim Investigational Site

    Milan

  • 205.389.2224 Boehringer Ingelheim Investigational Site

    Modena

  • 205.389.2203 Boehringer Ingelheim Investigational Site

    Montescano (PV)

  • 205.389.2230 Boehringer Ingelheim Investigational Site

    Naples

  • 205.389.2201 Boehringer Ingelheim Investigational Site

    Novara

  • 205.389.2229 Boehringer Ingelheim Investigational Site

    Pavia

  • 205.389.2227 Boehringer Ingelheim Investigational Site

    Pisa

  • 205.389.2205 Boehringer Ingelheim Investigational Site

    Roma

  • 205.389.2228 Boehringer Ingelheim Investigational Site

    Roma

  • 205.389.2210 Boehringer Ingelheim Investigational Site

    Sassari

  • 205.389.2232 Boehringer Ingelheim Investigational Site

    Treviso

Other trials in Italy

Israel14 sites

  • 205.389.2101 Boehringer Ingelheim Investigational Site

    Afula

  • 205.389.2110 Boehringer Ingelheim Investigational Site

    Ashkelon

  • 205.389.2106 Boehringer Ingelheim Investigational Site

    Beersheba

  • 205.389.2112 Boehringer Ingelheim Investigational Site

    Hadera

  • 205.389.2107 Boehringer Ingelheim Investigational Site

    Haifa

  • 205.389.2111 Boehringer Ingelheim Investigational Site

    Haifa

  • 205.389.2108 Boehringer Ingelheim Investigational Site

    Holon

  • 205.389.2104 Boehringer Ingelheim Investigational Site

    Jerusalem

  • 205.389.2114 Boehringer Ingelheim Investigational Site

    Jerusalem

  • 205.389.2116 Boehringer Ingelheim Investigational Site

    Nahariya

  • 205.389.2102 Boehringer Ingelheim Investigational Site

    Petah Tikva

  • 205.389.2105 Boehringer Ingelheim Investigational Site

    Rehovot

  • 205.389.2103 Boehringer Ingelheim Investigational Site

    Tel HaShomer

  • 205.389.2117 Boehringer Ingelheim Investigational Site

    Tsrifin

Other trials in Israel

Lithuania14 sites

  • 205.389.2401 Boehringer Ingelheim Investigational Site

    Alytus

  • 205.389.2402 Boehringer Ingelheim Investigational Site

    Kaunas

  • 205.389.2403 Boehringer Ingelheim Investigational Site

    Kaunas

  • 205.389.2404 Boehringer Ingelheim Investigational Site

    Kaunas

  • 205.389.2406 Boehringer Ingelheim Investigational Site

    Kaunas

  • 205.389.2409 Boehringer Ingelheim Investigational Site

    Kaunas

  • 205.389.2407 Boehringer Ingelheim Investigational Site

    Klaipėda

  • 205.389.2411 Boehringer Ingelheim Investigational Site

    Klaipėda

  • 205.389.2408 Boehringer Ingelheim Investigational Site

    Šiauliai

  • 205.389.2410 Boehringer Ingelheim Investigational Site

    Utena

  • 205.389.2405 Boehringer Ingelheim Investigational Site

    Vilnius

  • 205.389.2412 Boehringer Ingelheim Investigational Site

    Vilnius

  • 205.389.2413 Boehringer Ingelheim Investigational Site

    Vilnius

  • 205.389.2414 Boehringer Ingelheim Investigational Site

    Vilnius

Other trials in Lithuania

Latvia13 sites

  • 205.389.2315 Boehringer Ingelheim Investigational Site

    Balvi

  • 205.389.2305 Boehringer Ingelheim Investigational Site

    Daugavpils

  • 205.389.2313 Boehringer Ingelheim Investigational Site

    Jelgava

  • 205.389.2311 Boehringer Ingelheim Investigational Site

    Krāslava

  • 205.389.2312 Boehringer Ingelheim Investigational Site

    Kuldīga

  • 205.389.2301 Boehringer Ingelheim Investigational Site

    Riga

  • 205.389.2303 Boehringer Ingelheim Investigational Site

    Riga

  • 205.389.2307 Boehringer Ingelheim Investigational Site

    Riga

  • 205.389.2310 Boehringer Ingelheim Investigational Site

    Riga

  • 205.389.2306 Boehringer Ingelheim Investigational Site

    Talsi

  • 205.389.2314 Boehringer Ingelheim Investigational Site

    Tukums

  • 205.389.2304 Boehringer Ingelheim Investigational Site

    Valmiera

  • 205.389.2302 Boehringer Ingelheim Investigational Site

    Ventspils

Other trials in Latvia

Bulgaria12 sites

  • 205.389.3911 Boehringer Ingelheim Investigational Site

    Pazardzhik

  • 205.389.3903 Boehringer Ingelheim Investigational Site

    Plovdiv

  • 205.389.3915 Boehringer Ingelheim Investigational Site

    Plovdiv

  • 205.389.3918 Boehringer Ingelheim Investigational Site

    Rousse

  • 205.389.3914 Boehringer Ingelheim Investigational Site

    Sliven

  • 205.389.3902 Boehringer Ingelheim Investigational Site

    Sofia

  • 205.389.3906 Boehringer Ingelheim Investigational Site

    Sofia

  • 205.389.3907 Boehringer Ingelheim Investigational Site

    Sofia

  • 205.389.3908 Boehringer Ingelheim Investigational Site

    Stara Zagora

  • 205.389.3916 Boehringer Ingelheim Investigational Site

    Troyan Municipality

  • 205.389.3912 Boehringer Ingelheim Investigational Site

    Varna

  • 205.389.3901 Boehringer Ingelheim Investigational Site

    Veliko Tarnovo

Other trials in Bulgaria

Norway12 sites

  • 205.389.2614 Boehringer Ingelheim Investigational Site

    Ålesund

  • 205.389.2604 Boehringer Ingelheim Investigational Site

    Bekkestua

  • 205.389.2601 Boehringer Ingelheim Investigational Site

    Elverum

  • 205.389.2611 Boehringer Ingelheim Investigational Site

    Follebu

  • 205.389.2602 Boehringer Ingelheim Investigational Site

    Hamar

  • 205.389.2610 Boehringer Ingelheim Investigational Site

    Harstad

  • 205.389.2613 Boehringer Ingelheim Investigational Site

    Harstad

  • 205.389.2609 Boehringer Ingelheim Investigational Site

    Hønefoss

  • 205.389.2608 Boehringer Ingelheim Investigational Site

    Lørenskog

  • 205.389.2605 Boehringer Ingelheim Investigational Site

    Oslo

  • 205.389.2612 Boehringer Ingelheim Investigational Site

    Oslo

  • 205.389.2616 Boehringer Ingelheim Investigational Site

    Stavanger

Other trials in Norway

Turkey (Türkiye)12 sites

  • 205.389.3821 Boehringer Ingelheim Investigational Site

    Adana

  • 205.389.3808 Boehringer Ingelheim Investigational Site

    Ankara

  • 205.389.3810 Boehringer Ingelheim Investigational Site

    Ankara

  • 205.389.3817 Boehringer Ingelheim Investigational Site

    Bursa

  • 205.389.3819 Boehringer Ingelheim Investigational Site

    Erzurum

  • 205.389.3812 Boehringer Ingelheim Investigational Site

    Istanbul

  • 205.389.3827 Boehringer Ingelheim Investigational Site

    Izmir

  • 205.389.3813 Boehringer Ingelheim Investigational Site

    İzmit

  • 205.389.3820 Boehringer Ingelheim Investigational Site

    Kahramanmaraş

  • 205.389.3825 Boehringer Ingelheim Investigational Site

    Malatya

  • 205.389.3809 Boehringer Ingelheim Investigational Site

    Sihhiye Ankara

  • 205.389.3807 Boehringer Ingelheim Investigational Site

    Yenisehir-IZMIR

Other trials in Turkey (Türkiye)

Belgium11 sites

  • 205.389.1120 Boehringer Ingelheim Investigational Site

    Buizingen

  • 205.389.1124 Boehringer Ingelheim Investigational Site

    Cerexhe-Heuseux

  • 205.389.1116 Boehringer Ingelheim Investigational Site

    Chenée (Liége)

  • 205.389.1121 Boehringer Ingelheim Investigational Site

    Dour

  • 205.389.1113 Boehringer Ingelheim Investigational Site

    Gembloux

  • 205.389.1117 Boehringer Ingelheim Investigational Site

    Gozée

  • 205.389.1126 Boehringer Ingelheim Investigational Site

    Hasselt

  • 205.389.1129 Boehringer Ingelheim Investigational Site

    Natoye

  • 205.389.1130 Boehringer Ingelheim Investigational Site

    Quaregnon

  • 205.389.1115 Boehringer Ingelheim Investigational Site

    Thuillies

  • 205.389.1107 Boehringer Ingelheim Investigational Site

    Wetteren

Other trials in Belgium

Denmark10 sites

  • 205.389.1304 Boehringer Ingelheim Investigational Site

    Copenhagen

  • 205.389.1301 Boehringer Ingelheim Investigational Site

    Elsinore

  • 205.389.1308 Boehringer Ingelheim Investigational Site

    Elsinore

  • 205.389.1309 Boehringer Ingelheim Investigational Site

    Frederikssund

  • 205.389.1311 Boehringer Ingelheim Investigational Site

    Holstebro

  • 205.389.1302 Boehringer Ingelheim Investigational Site

    Næstved

  • 205.389.1303 Boehringer Ingelheim Investigational Site

    Roskilde

  • 205.389.1310 Boehringer Ingelheim Investigational Site

    Skive

  • 205.389.1312 Boehringer Ingelheim Investigational Site

    Sønderborg

  • 205.389.1307 Boehringer Ingelheim Investigational Site

    Værløse

Other trials in Denmark

Finland10 sites

  • 205.389.1402 Boehringer Ingelheim Investigational Site

    Helsinki

  • 205.389.1416 Boehringer Ingelheim Investigational Site

    Hyvinkää

  • 205.389.1410 Boehringer Ingelheim Investigational Site

    Jyväskylä

  • 205.389.1404 Boehringer Ingelheim Investigational Site

    Lahti

  • 205.389.1417 Boehringer Ingelheim Investigational Site

    Lappeenranta

  • 205.389.1415 Boehringer Ingelheim Investigational Site

    Lohja

  • 205.389.1411 Boehringer Ingelheim Investigational Site

    Mikkeli

  • 205.389.1409 Boehringer Ingelheim Investigational Site

    Pori

  • 205.389.1412 Boehringer Ingelheim Investigational Site

    Preitilä Paimio

  • 205.389.1407 Boehringer Ingelheim Investigational Site

    Turku

Other trials in Finland

Portugal10 sites

  • 205.389.2912 Boehringer Ingelheim Investigational Site

    Angra do Heroísmo

  • 205.389.2911 Boehringer Ingelheim Investigational Site

    Barreiro

  • 205.389.2904 Boehringer Ingelheim Investigational Site

    Faro

  • 205.389.2910 Boehringer Ingelheim Investigational Site

    Figueira da Foz Municipality

  • 205.389.2907 Boehringer Ingelheim Investigational Site

    Guarda

  • 205.389.2914 Boehringer Ingelheim Investigational Site

    Lisbon

  • 205.389.2917 Boehringer Ingelheim Investigational Site

    Lisbon

  • 205.389.2905 Boehringer Ingelheim Investigational Site

    Santa Maria da Feira

  • 205.389.2909 Boehringer Ingelheim Investigational Site

    Santiago do Cacém

  • 205.389.2903 Boehringer Ingelheim Investigational Site

    Torres Vedras

Other trials in Portugal

Slovakia8 sites

  • 205.389.3208 Boehringer Ingelheim Investigational Site

    Bratislava

  • 205.389.3204 Boehringer Ingelheim Investigational Site

    Košice

  • 205.389.3209 Boehringer Ingelheim Investigational Site

    Košice

  • 205.389.3205 Boehringer Ingelheim Investigational Site

    Prievidza

  • 205.389.3210 Boehringer Ingelheim Investigational Site

    Revúca

  • 205.389.3203 Boehringer Ingelheim Investigational Site

    Spišská Nová Ves

  • 205.389.3202 Boehringer Ingelheim Investigational Site

    Trnava

  • 205.389.3207 Boehringer Ingelheim Investigational Site

    Vráble

Other trials in Slovakia

Slovenia6 sites

  • 205.389.3301 Boehringer Ingelheim Investigational Site

    Golnik

  • 205.389.3308 Boehringer Ingelheim Investigational Site

    Grosuplje

  • 205.389.3304 Boehringer Ingelheim Investigational Site

    Jesenice

  • 205.389.3302 Boehringer Ingelheim Investigational Site

    Kamnik

  • 205.389.3303 Boehringer Ingelheim Investigational Site

    Ljubljana

  • 205.389.3306 Boehringer Ingelheim Investigational Site

    Topolšica

Other trials in Slovenia

Netherlands4 sites

  • 205.389.2504 Boehringer Ingelheim Investigational Site

    Rotterdam

  • 205.389.2508 Boehringer Ingelheim Investigational Site

    Te Leiderdrop

  • 205.389.2510 Boehringer Ingelheim Investigational Site

    Velp

  • 205.389.2511 Boehringer Ingelheim Investigational Site

    Zoetermeer

Other trials in Netherlands

About this study

Official title: Effect of Inhalation of Tiotropium Once Daily 18 Mcg Versus Salmeterol Twice Daily 50 Mcg on Time to First Exacerbation in COPD Patients (a Randomised, Double-blind, Double-dummy, Parallel Group, One-year Study).

This is a randomised, double-blind, double-dummy, multinational, multicentre, parallel group trial comparing tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg) via MDI in patients with COPD. There will be a two-week run-in period followed by a 52-week randomised treatment phase. Patients who withdraw prematurely from trial medication will be encouraged to remain in the trial and participate in follow-up telephone contacts until their predicted normal exit date from the trial (i.e. 52 weeks after taking the first dose of randomised treatment). The phone calls will be made at all scheduled visits.

The primary objective of this study is to compare the effect of tiotropium (18 mcg) inhalation capsule via HandiHaler with that of salmeterol (50 mcg) via MDI on COPD exacerbations.

Read more

The primary endpoint is time to first COPD exacerbation during the 52 week randomised treatment period. A COPD exacerbation will be defined as a complex of respiratory events / symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnoea or chest tightness with at least one symptom lasting at least three days requiring treatment with antibiotics and/or systemic steroids and/or hospitalisation.

The onset of an exacerbation is defined as the onset of the first new or increased reported symptom. The end of the exacerbation should be recorded as defined by the investigator.

Only COPD exacerbations with onset during randomised treatment will be included in the analysis.

Being tested
Tiotropium bromide, Salmeterol, Placebo Salmeterol, Placebo Tiotropium
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tiotropium bromideDrug

    18 mcg/daily

  • SalmeterolDrug

    100 mcg/daily

  • Placebo SalmeterolDrug

    Placebo identical to Salmeterol device

  • Placebo TiotropiumDrug

    Placebo identical to Tiotropium device

Study groups in NCT00563381
Study groupRoleWhat they receive
Tiotropium + PlaceboActive comparatorpatients inhale Tiotropium 18mcg once daily via HandiHaler and Placebo MDI twice daily
Receives: Drug: Tiotropium bromide; Drug: Placebo Salmeterol
Salmeterol + PlaceboActive comparatorpatients inhale Salmeterol 50mcg twice daily via MDI and Placebo HandiHaler once daily
Receives: Drug: Salmeterol; Drug: Placebo Tiotropium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First Occurrence of (Moderate or Severe) COPD Exacerbation

    First occurrence analysed by Cox regression as time to first exacerbation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).

    Measured: 52 weeks

Secondary outcomes (30)

  1. COPD Exacerbations Per Patient-year Leading to Hospitalisation

    An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).

    Measured: 52 weeks

  2. Number of Participants With at Least One COPD Exacerbation

    An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).

    Measured: 52 weeks

  3. COPD Exacerbations Per Patient-year

    Measured: 52 weeks

  4. First Occurrence of COPD Exacerbation Leading to Hospitalization

    First occurrence analysed by Cox regression as time to first exacerbation leading to hospitalisation and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).

    Measured: 52 weeks

  5. Number of Participants With at Least One COPD Exacerbation Leading to Hospitalisation

    An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).

    Measured: 52 weeks

  6. Occurrence of Premature Discontinuation of Trial Medication

    Occurrence analysed by Cox regression as time to premature discontinuation of trial medication and reported as hazard ratio

    Measured: 52 weeks

  7. Number of Participants With Premature Discontinuation of Trial Medication

    Measured: 52 weeks

  8. First Occurrence of COPD Exacerbation or Discontinuation of Trial Medication Because of Worsening of Underlying Disease, Whichever Comes First

    First occurrence analysed by Cox regression as time to first exacerbation or discontinuation of trial medication because of worsening of underlying disease, whichever comes first and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).

    Measured: 52 weeks

  9. First Occurrence of COPD Exacerbations Treated With Systemic Steroids

    First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).

    Measured: 52 weeks

  10. First Occurrence of COPD Exacerbations Treated With Antibiotics

    First occurrence analysed by Cox regression as time to first exacerbation treated with antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).

    Measured: 52 weeks

  11. First Occurrence of COPD Exacerbations Treated With Systemic Steroids and Antibiotics

    First occurrence analysed by Cox regression as time to first exacerbation treated with systemic steroids and antibiotics and reported as hazard ratio. An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).

    Measured: 52 weeks

  12. COPD Exacerbations Treated With Systemic Steroids Per Patient-year

    An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).

    Measured: 52 weeks

  13. COPD Exacerbations Treated With Antibiotics Per Patient-year

    An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).

    Measured: 52 weeks

  14. COPD Exacerbations Treated With Systemic Steroids and Antibiotics Per Patient-year

    An exacerbation was defined as an increase or new onset of more than 1 symptom (cough, sputum, wheezing, dyspnoea, chest tightness), with at least 1 symptom lasting at least 3 days and requiring treatment with systemic steroids and/or antibiotics (moderate exacerbation) or hospitalisation (severe exacerbation).

    Measured: 52 weeks

  15. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 1

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  16. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 2

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  17. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 3

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  18. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 4

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  19. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 5

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  20. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 6

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  21. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 7

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  22. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 8

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  23. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 9

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  24. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 10

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  25. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 11

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  26. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 12

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  27. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 13

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  28. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 14

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  29. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 15

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

  30. Pre-dose Morning PEFR Measured by Patients at Home During the First Four Months of Randomised Treatment (Weekly Means Will be Calculated), Week 16

    PEFR means peak expiratory flow rate and is measured in liter per minute

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2007 (estimated)
  2. Study startJan 2008
  3. Primary completionApr 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
7,376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00563381
Sponsor's protocol ID
205.389
Other IDs
EUDRACT2007-001840-33
Status last verified
Jul 2012
First submitted
22 Nov 2007
Last updated
24 Dec 2013

Publications

  • Vogelmeier CF, Asijee GM, Kupas K, Beeh KM. Tiotropium and Salmeterol in COPD Patients at Risk of Exacerbations: A Post Hoc Analysis from POET-COPD((R)). Adv Ther. 2015 Jun;32(6):537-47. doi: 10.1007/s12325-015-0216-2. Epub 2015 Jun 23.

    PubMed 26100349

  • Rabe KF, Fabbri LM, Israel E, Kogler H, Riemann K, Schmidt H, Glaab T, Vogelmeier CF. Effect of ADRB2 polymorphisms on the efficacy of salmeterol and tiotropium in preventing COPD exacerbations: a prespecified substudy of the POET-COPD trial. Lancet Respir Med. 2014 Jan;2(1):44-53. doi: 10.1016/S2213-2600(13)70248-0. Epub 2013 Dec 5.

    PubMed 24461901

  • Beeh KM, Glaab T, Stowasser S, Schmidt H, Fabbri LM, Rabe KF, Vogelmeier CF. Characterisation of exacerbation risk and exacerbator phenotypes in the POET-COPD trial. Respir Res. 2013 Oct 29;14(1):116. doi: 10.1186/1465-9921-14-116.

    PubMed 24168767

  • Rabe KF, Fabbri LM, Vogelmeier C, Kogler H, Schmidt H, Beeh KM, Glaab T. Seasonal distribution of COPD exacerbations in the Prevention of Exacerbations with Tiotropium in COPD trial. Chest. 2013 Mar;143(3):711-719. doi: 10.1378/chest.12-1277.

    PubMed 23188489

  • Vogelmeier C, Hederer B, Glaab T, Schmidt H, Rutten-van Molken MP, Beeh KM, Rabe KF, Fabbri LM; POET-COPD Investigators. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med. 2011 Mar 24;364(12):1093-1103. doi: 10.1056/NEJMoa1008378.

    PubMed 21428765

  • Beeh KM, Hederer B, Glaab T, Muller A, Rutten-van Moelken M, Kesten S, Vogelmeier C. Study design considerations in a large COPD trial comparing effects of tiotropium with salmeterol on exacerbations. Int J Chron Obstruct Pulmon Dis. 2009;4:119-25. Epub 2009 Apr 15.

    PubMed 19436693

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tiotropium bromide and Salmeterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 752 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 752 sites in Germany, Poland, Russia, Ukraine, France and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First Occurrence of (Moderate or Severe) COPD Exacerbation (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00563381, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in