AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructivePhase 3NCT00144339

Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients

A Phase 3 study testing tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 490 sites in 37 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

The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD. 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,993 participants
Where
490 sitesin 37 countries
Study dates
Dec 2002to Feb 2008
Phase
Phase 3
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

  • Written informed consent.
  • Male or female patients 40 years of age or older.
  • Smoking history of at least 10 pack years.
  • Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1<70% of FVC and on stable respiratory medication.

Who cannot join

  • Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.
  • Myocardial infarction in past 6 months.
  • Unstable or life threatening arrhythmia in past year.
  • Hospitalization for NYHA heart failure class III or IV in past year.
  • Active tuberculosis.
  • Asthma.
Show all 15Show fewer
  • Pulmonary resection.
  • Malignancy treated with radiation or chemotherapy in past 5 years.
  • Respiratory infection in 4 weeks prior to screening.
  • Known hypersensitivity to anticholinergic drugs or components.
  • Known moderate to severe renal impairment.
  • Known narrow angle glaucoma.
  • Significant symptomatic BPH or bladder neck obstruction.
  • Need for oxygen therapy >12 hr/day.
  • Use of oral corticosteroids at unstable doses or >10 mg/day.

Trial locations and contacts

490 sites in 37 countries.

490 sites in 37 countries

United States95 sites

  • 205.235.3796 Boehringer Ingelheim Investigational Site

    Albany, New York

  • 205.235.3813 Boehringer Ingelheim Investigational Site

    Ann Arbor, Michigan

  • 205.235.3779 Boehringer Ingelheim Investigational Site

    Anniston, Alabama

  • 205.235.3719 Boehringer Ingelheim Investigational Site

    Atlanta, Georgia

  • 205.235.3790 Boehringer Ingelheim Investigational Site

    Atlanta, Georgia

  • 205.235.3716 Boehringer Ingelheim Investigational Site

    Augusta, Georgia

  • 205.235.3806 Boehringer Ingelheim Investigational Site

    Baltimore, Maryland

  • 205.235.3706 Boehringer Ingelheim Investigational Site

    Bay Pines, Florida

  • 205.235.3807 Boehringer Ingelheim Investigational Site

    Bay Shore, New York

  • 205.235.3750 Boehringer Ingelheim Investigational Site

    Bidderford, Maine

  • 205.235.3785 Boehringer Ingelheim Investigational Site

    Birmingham, Alabama

  • 205.235.3721 Boehringer Ingelheim Investigational Site

    Boston, Massachusetts

  • 205.235.3762 Boehringer Ingelheim Investigational Site

    Brandon, Florida

  • 205.235.3730 Boehringer Ingelheim Investigational Site

    Burlington, North Carolina

  • 205.235.3770 Boehringer Ingelheim Investigational Site

    Carmichael, California

  • 205.235.3731 Boehringer Ingelheim Investigational Site

    Chapel Hill, North Carolina

  • 205.235.3797 Boehringer Ingelheim Investigational Site

    Cherry Hill, New Jersey

  • 205.235.3734 Boehringer Ingelheim Investigational Site

    Chesterfield, Missouri

  • 205.235.3723 Boehringer Ingelheim Investigational Site

    Cincinnati, Ohio

  • 205.235.3701 Boehringer Ingelheim Investigational Site

    Cleveland, Ohio

  • 205.235.3724 Boehringer Ingelheim Investigational Site

    Coeur d'Alene, Idaho

  • 205.235.3744 Boehringer Ingelheim Investigational Site

    Danville, Virginia

  • 205.235.3764 Boehringer Ingelheim Investigational Site

    Denver, Colorado

  • 205.235.3732 Boehringer Ingelheim Investigational Site

    Detroit, Michigan

  • 205.235.3749 Boehringer Ingelheim Investigational Site

    Dubuque, Iowa

  • 205.235.3736 Boehringer Ingelheim Investigational Site

    Durham, North Carolina

  • 205.235.3803 Boehringer Ingelheim Investigational Site

    El Paso, Texas

  • 205.235.3745 Boehringer Ingelheim Investigational Site

    Elizabath City, North Carolina

  • 205.235.3778 Boehringer Ingelheim Investigational Site

    Escondito, California

  • 205.235.3782 Boehringer Ingelheim Investigational Site

    Fredericksburg, Virginia

  • 205.235.3727 Boehringer Ingelheim Investigational Site

    Hartford, Connecticut

  • 205.235.3808 Boehringer Ingelheim Investigational Site

    Hartford, Connecticut

  • 205.235.3725 Boehringer Ingelheim Investigational Site

    Hershey, Pennsylvania

  • 205.235.3742 Boehringer Ingelheim Investigational Site

    Houston, Texas

  • 205.235.3787 Boehringer Ingelheim Investigational Site

    Houston, Texas

  • 205.235.3768 Boehringer Ingelheim Investigational Site

    Indianapolis, Indiana

  • 205.235.3804 Boehringer Ingelheim Investigational Site

    Jasper, Alabama

  • 205.235.3814 Boehringer Ingelheim Investigational Site

    Kansas City, Missouri

  • 205.235.3780 Boehringer Ingelheim Investigational Site

    La Crosse, Wisconsin

  • 205.235.3810 Boehringer Ingelheim Investigational Site

    Lakewood, California

  • 205.235.3765 Boehringer Ingelheim Investigational Site

    Larchmont, New York

  • 205.235.3707 Boehringer Ingelheim Investigational Site

    Largo, Florida

  • 205.235.3763 Boehringer Ingelheim Investigational Site

    Lebanon, New Hampshire

  • 205.235.3729 Boehringer Ingelheim Investigational Site

    Lexington, Kentucky

  • 205.235.3809 Boehringer Ingelheim Investigational Site

    Livonia, Michigan

  • 205.235.3758 Boehringer Ingelheim Investigational Site

    Long Beach, California

  • 205.235.3812 Boehringer Ingelheim Investigational Site

    Long Beach, California

  • 205.235.3773 Boehringer Ingelheim Investigational Site

    Los Angeles, California

  • 205.235.3800 Boehringer Ingelheim Investigational Site

    Los Angeles, California

  • 205.235.3802 Boehringer Ingelheim Investigational Site

    Los Angeles, California

  • 205.235.3771 Boehringer Ingelheim Investigational Site

    Lynchburg, Virginia

  • 205.235.3703 Boehringer Ingelheim Investigational Site

    Melbourne, Florida

  • 205.235.3737 Boehringer Ingelheim Investigational Site

    Metairie, Louisiana

  • 205.235.3748 Boehringer Ingelheim Investigational Site

    Mineola, New York

  • 205.235.3751 Boehringer Ingelheim Investigational Site

    Minneapolis, Minnesota

  • 205.235.3754 Boehringer Ingelheim Investigational Site

    Minneapolis, Minnesota

  • 205.235.3795 Boehringer Ingelheim Investigational Site

    Mobile, Alabama

  • 205.235.3818 Boehringer Ingelheim Investigational Site

    New York, New York

  • 205.235.3713 Boehringer Ingelheim Investigational Site

    Normal, Illinois

  • 205.235.3793 Boehringer Ingelheim Investigational Site

    Norwalk, Connecticut

  • 205.235.3757 Boehringer Ingelheim Investigational Site

    Olathe, Kansas

  • 205.235.3786 Pulmonary and Critical Care Medicine

    Orange, California

  • 205.235.3811 Boehringer Ingelheim Investigational Site

    Palo Alto, California

  • 205.235.3775 Boehringer Ingelheim Investigational Site

    Panama City, Florida

  • 205.235.3817 Boehringer Ingelheim Investigational Site

    Philadelphia, Pennsylvania

  • 205.235.3759 Boehringer Ingelheim Investigational Site

    Phoenix, Arizona

  • 205.235.3820 Boehringer Ingelheim Investigational Site

    Portland, Oregon

  • 205.235.3715 Boehringer Ingelheim Investigational Site

    Providence, Rhode Island

  • 205.235.3741 Boehringer Ingelheim Investigational Site

    Rancho Mirage, California

  • 205.235.3738 Boehringer Ingelheim Investigational Site

    Richmond, Virginia

  • 205.235.3792 Boehringer Ingelheim Investigational Site

    Richmond, Virginia

  • 205.235.3789 Boehringer Ingelheim Investigational Site

    Rochester, Minnesota

  • 205.235.3722 Boehringer Ingelheim Investigational Site

    Rochester, New York

  • 205.235.3761 Boehringer Ingelheim Investigational Site

    Salem, Virginia

  • 205.235.3752 Boehringer Ingelheim Investigational Site

    Salt Lake City, Utah

  • 205.235.3704 Boehringer Ingelheim Investigational Site

    San Antonio, Texas

  • 205.235.3717 Boehringer Ingelheim Investigational Site

    San Diego, California

  • 205.235.3781 Boehringer Ingelheim Investigational Site

    San Diego, California

  • 205.235.3784 Boehringer Ingelheim Investigational Site

    San Diego, California

  • 205.235.3743 Boehringer Ingelheim Investigational Site

    Sarasota, Florida

  • 205.235.3760 Boehringer Ingelheim Investigational Site

    Sepulveda, California

  • 205.235.3788 Boehringer Ingelheim Investigational Site

    Shreveport, Louisiana

  • 205.235.3718 Boehringer Ingelheim Investigational Site

    Spokane, Washington

  • 205.235.3726 354 Birnie Ave

    Springfield, Massachusetts

  • 205.235.3747 Boehringer Ingelheim Investigational Site

    St Louis, Missouri

  • 205.235.3794 Boehringer Ingelheim Investigational Site

    Stockbridge, Georgia

  • 205.235.3711 Boehringer Ingelheim Investigational Site

    Stockton, California

  • 205.235.3799 Boehringer Ingelheim Investigational Site

    Summit, New Jersey

  • 205.235.3756 Boehringer Ingelheim Investigational Site

    Tampa, Florida

  • 205.235.3816 Boehringer Ingelheim Investigational Site

    The Bronx, New York

  • 205.235.3791 Boehringer Ingelheim Investigational Site

    Tulsa, Oklahoma

  • 205.235.3815 Boehringer Ingelheim Investigational Site

    West Haven, Connecticut

  • 205.235.3739 Boehringer Ingelheim Investigational Site

    West Palm Beach, Florida

  • 205.235.3783 Boehringer Ingelheim Investigational Site

    Wheat Ridge, Colorado

  • 205.235.3712 Boehringer Ingelheim Investigational Site

    Winston-Salem, North Carolina

Other trials in United States

Spain36 sites

  • 205.235.3014 Complejo Hospitalario Juan Canalejo

    A Coruña

  • 205.235.3026 Hospital General Universitario de Alicante

    Alicante

  • 205.235.3011 Complejo Hospitalario Infanta Cristina

    Badajoz

  • 205.235.3006 Hospital Germans Trias i Pujol

    Badalona (Barcelona)

  • 205.235.3022 Hospital de Cruces

    Barakaldo (Bilbao)

  • 205.235.3003 Hospital Clínic i Provincial de Barcelona

    Barcelona

  • 205.235.3008 Hospital Vall d'Hebrón

    Barcelona

  • 205.235.3023 Hospital Dr. Josep Trueta

    Girona

  • 205.235.3004 Hospital General Universitario de Guadalajara

    Guadalajara

  • 205.235.3005 Hospital General San Jorge de Huesca

    Huesca

  • 205.235.3021 Hospital de Jerez de la Frontera

    Jerez de la Frontera

  • 205.235.3010 Hospital Severo Ochoa

    Leganés, Madrid

  • 205.235.3009 Hospital Clínico San Carlos

    Madrid

  • 205.235.3013 Clínica Puerta de Hierro

    Madrid

  • 205.235.3017 Hospital Ramón y Cajal

    Madrid

  • 205.235.3020 Hospital Universitario La Paz

    Madrid

  • 205.235.3028 Hospital Universitario de la Princesa

    Madrid

  • 205.235.3031 Hospital Gregorio Marañón

    Madrid

  • 205.235.3036 Hospital 12 de Octubre

    Madrid

  • 205.235.3033 Hospital General Carlos Haya

    Málaga

  • 205.235.3027 Complejo Asistencial Son Dureta

    Palma de Mallorca

  • 205.235.3024 Hospital de Montecelo

    Pontevedra

  • 205.235.3016 Hospital Universitari de Sant Joan

    Reus (Tarragona)

  • 205.235.3015 Corporació Sanitaria Parc Taulí de Sabadell

    Sabadell (Barcelona)

  • 205.235.3037 Hsopital Universitario Ntra. Sra. de la Candelaria

    Santa Cruz de Tenerife

  • 205.235.3039 Hospital Universitario Marqués de Valdecilla

    Santander

  • 205.235.3019 Hospital Vírgen de la Macarena

    Seville

  • 205.235.3035 Hospital Universitario Vírgen del Rocío

    Seville

  • 205.235.3001 Hospital Mutua Terrassa

    Terrassa (Barcelona)

  • 205.235.3002 Hospital Clínico Universitario de Valencia

    Valencia

  • 205.235.3025 Hospital Universitario Dr. Peset

    Valencia

  • 205.235.3032 Hospital Arnau de Vilanova

    Valencia

  • 205.235.3034 Hospital La Fe

    Valencia

  • 205.235.3018 Complejo Hospitalario Xeral - Cíes

    Vigo

  • 205.235.3030 Hospital Miguel Servet

    Zaragoza

  • 205.235.3038 Hospital Clínico Lozano Blesa

    Zaragoza

Other trials in Spain

Italy31 sites

  • 205.235.1631 A. O. SS. Antonio e Biagio e Arrigo

    Alessandria

  • 205.235.1613 A. O. S. Giuseppe Moscati

    Avellino

  • 205.235.1618 Ospedale Bellaria

    Bologna

  • 205.235.1649 Ospedale di Circolo di Busto Arsizio

    Busto Arsizio (VA)

  • 205.235.1635 P. O. Roberto Binaghi

    Cagliari

  • 205.235.1623 A. O. di Carrara

    Carrara (Massa)

  • 205.235.1645 Ospedale Civile "Zappatoni"

    Cassano D'adda (Milano)

  • 205.235.1617 Ospedale S. Camillo De Lellis

    Chieti

  • 205.235.1612 A. O. S. Antonio Abate

    Erice (Trapani)

  • 205.235.1622 A. O. S. Anna

    Ferrara

  • 205.235.1646 A. O. di Careggi

    Florence

  • 205.235.1647 A. O. Careggi

    Florence

  • 205.235.1615 Ospedale S. Martino

    Genova

  • 205.235.1603 P. O. di Gubbio

    Gubbio (Perugia)

  • 205.235.1619 A. O. Fratelli Crobu

    Iglesias (Cagliari)

  • 205.235.1648 Ospedale "S. Maria di Collemaggio"

    L’Aquila

  • 205.235.1634 P. O. Luigi Sacco

    Milan

  • 205.235.1639 Ospedale Maggiore

    Modica (Ragusa)

  • 205.235.1629 A. O. S. Luigi Gonzaga

    Orbassano (Torino)

  • 205.235.1604 P. O. R. Silvestrini

    Perugia

  • 205.235.1601 Presidio Ospedaliero di Cisanello

    Pisa

  • 205.235.1643 A. O. Santa Maria degli Angeli

    Pordenone

  • 205.235.1614 Ospedale Misericordia e Dolce

    Prato

  • 205.235.1624 Ospedale di Macerata

    Province of Macerata

  • 205.235.1607 Università degli Studi di Sassari

    Sassari

  • 205.235.1608 ASL 1 di Sassari

    Sassari

  • 205.235.1606 ASL 4 di Terni

    Terni

  • 205.235.1632 ASL 4 - Distretto 2

    Torino

  • 205.235.1633 A. O. Umberto I

    Torrette Di Ancona (Ancona)

  • 205.235.1640 P. O. Cà Foncello

    Treviso

  • 205.235.1602 Ospedale di Voghera

    Voghera (Pavia)

Other trials in Italy

Denmark29 sites

  • 205.235.0804 Boehringer Ingelheim Investigational Site

    Aalborg

  • 205.235.0826 Boehringer Ingelheim Investigational Site

    Aalborg SV

  • 205.235.0803 Boehringer Ingelheim Investigational Site

    Aarhus

  • 205.235.0831 Boehringer Ingelheim Investigational Site

    Copenhagen

  • 205.235.0828 Boehringer Ingelheim Investigational Site

    Copenhagen K

  • 205.235.0802 Boehringer Ingelheim Investigational Site

    Copenhagen NV

  • 205.235.0816 Boehringer Ingelheim Investigational Site

    Elsinore

  • 205.235.0807 Boehringer Ingelheim Investigational Site

    Fåborg

  • 205.235.0821 Boehringer Ingelheim Investigational Site

    Frederikshavn

  • 205.235.0832 Boehringer Ingelheim Investigational Site

    Frederikssund

  • 205.235.0805 Boehringer Ingelheim Investigational Site

    Hellerup

  • 205.235.0835 Boehringer Ingelheim Investigational Site

    Hellerup

  • 205.235.0811 Boehringer Ingelheim Investigational Site

    Hillerød

  • 205.235.0834 Boehringer Ingelheim Investigational Site

    Hobro

  • 205.235.0806 Boehringer Ingelheim Investigational Site

    Holbæk

  • 205.235.0814 Boehringer Ingelheim Investigational Site

    Holstebro

  • 205.235.0801 Boehringer Ingelheim Investigational Site

    Hvidovre

  • 205.235.0833 Boehringer Ingelheim Investigational Site

    Kalundborg

  • 205.235.0830 Boehringer Ingelheim Investigational Site

    Kolding

  • 205.235.0810 Boehringer Ingelheim Investigational Site

    Næstved

  • 205.235.0819 Boehringer Ingelheim Investigational Site

    Nykøbing Falster

  • 205.235.0809 Boehringer Ingelheim Investigational Site

    Odense C

  • 205.235.0815 Boehringer Ingelheim Investigational Site

    Randers

  • 205.235.0824 Boehringer Ingelheim Investigational Site

    Silkeborg

  • 205.235.0813 Boehringer Ingelheim Investigational Site

    Skive

  • 205.235.0822 Boehringer Ingelheim Investigational Site

    Skive

  • 205.235.0820 Boehringer Ingelheim Investigational Site

    Slagelse

  • 205.235.0808 Boehringer Ingelheim Investigational Site

    Svendborg

  • 205.235.0827 Boehringer Ingelheim Investigational Site

    Værløse

Other trials in Denmark

Belgium27 sites

  • 205.235.0439 Boehringer Ingelheim Investigational Site

    Anderlecht

  • 205.235.0429 Boehringer Ingelheim Investigational Site

    Baudour

  • 205.235.0421 Boehringer Ingelheim Investigational Site

    Bruges

  • 205.235.0424 Boehringer Ingelheim Investigational Site

    Brussels

  • 205.235.0432 Boehringer Ingelheim Investigational Site

    Brussels

  • 205.235.0434 Boehringer Ingelheim Investigational Site

    Brussels

  • 205.235.0422 Boehringer Ingelheim Investigational Site

    Dendermonde

  • 205.235.0405 Boehringer Ingelheim Investigational Site

    Edegem

  • 205.235.0414 Boehringer Ingelheim Investigational Site

    Ghent

  • 205.235.0418 U.Z. Gent

    Ghent

  • 205.235.0417 Boehringer Ingelheim Investigational Site

    Herentals

  • 205.235.0402 Boehringer Ingelheim Investigational Site

    Ieper

  • 205.235.0409 Boehringer Ingelheim Investigational Site

    Kortrijk

  • 205.235.0407 Boehringer Ingelheim Investigational Site

    Leuven

  • 205.235.0440 Boehringer Ingelheim Investigational Site

    Luxembourg

  • 205.235.0403 Boehringer Ingelheim Investigational Site

    Menen

  • 205.235.0406 Boehringer Ingelheim Investigational Site

    Merksem

  • 205.235.0404 Boehringer Ingelheim Investigational Site

    Middelheim

  • 205.235.0438 Boehringer Ingelheim Investigational Site

    Mons

  • 205.235.0437 Boehringer Ingelheim Investigational Site

    Namur

  • 205.235.0420 Boehringer Ingelheim Investigational Site

    Neerpelt

  • 205.235.0435 Boehringer Ingelheim Investigational Site

    Nobressart (attert)

  • 205.235.0423 Boehringer Ingelheim Investigational Site

    Ostend

  • 205.235.0433 Boehringer Ingelheim Investigational Site

    Tournai

  • 205.235.0412 Boehringer Ingelheim Investigational Site

    Turnhout

  • 205.235.0413 Boehringer Ingelheim Investigational Site

    Turnhout

  • 205.235.0428 Boehringer Ingelheim Investigational Site

    Yvoir

Other trials in Belgium

Czechia26 sites

  • 205.235.0712 Boehringer Ingelheim Investigational Site

    Benešov

  • 205.235.0711 Boehringer Ingelheim Investigational Site

    Beroun

  • 205.235.0718 Clinic of Functional Diagnostics and Rehabilitation

    Brno

  • 205.235.0725 University Hospital Brno

    Brno

  • 205.235.0720 Office of Pulmonology and Respiratory Diseases

    Český Těšín

  • 205.235.0717 Pulmonary Clinic

    Hradec Králové

  • 205.235.0705 Boehringer Ingelheim Investigational Site

    Jablonec nad Nisou

  • 205.235.0726 Private Office of Pulmonary Diseases

    Jaroměř

  • 205.235.0722 Hospital Kromeriz

    Kroměříž

  • 205.235.0724 District Hospital Kyjov

    Kyjov

  • 205.235.0704 Boehringer Ingelheim Investigational Site

    Lovosice

  • 205.235.0702 Boehringer Ingelheim Investigational Site

    Mariánské Lázně

  • 205.235.0701 Boehringer Ingelheim Investigational Site

    Pilsen

  • 205.235.0703 Boehringer Ingelheim Investigational Site

    Pilsen

  • 205.235.0706 Boehringer Ingelheim Investigational Site

    Prague

  • 205.235.0707 Boehringer Ingelheim Investigational Site

    Prague

  • 205.235.0709 Boehringer Ingelheim Investigational Site

    Prague

  • 205.235.0710 Boehringer Ingelheim Investigational Site

    Prague

  • 205.235.0715 Boehringer Ingelheim Investigational Site

    Prague

  • 205.235.0708 Boehringer Ingelheim Investigational Site

    Praha 5 - Nove Butovice

  • 205.235.0723 Office of Pulmonary and Respiratory Diseases

    Přerov

  • 205.235.0721 Office of Pulmonary Diseases

    Příbor

  • 205.235.0713 Boehringer Ingelheim Investigational Site

    Strakonice

  • 205.235.0714 Boehringer Ingelheim Investigational Site

    Tábor

  • 205.235.0719 Office of Pulmonology and Respiratory Diseases

    Ústí nad Orlicí

  • 205.235.0716 Boehringer Ingelheim Investigational Site

    Znojmo

Other trials in Czechia

Hungary20 sites

  • 205.235.1303 Boehringer Ingelheim Investigational Site

    Budapest

  • 205.235.1308 Boehringer Ingelheim Investigational Site

    Budapest

  • 205.235.1309 Boehringer Ingelheim Investigational Site

    Budapest

  • 205.235.1310 Boehringer Ingelheim Investigational Site

    Budapest

  • 205.235.1311 Boehringer Ingelheim Investigational Site

    Budapest

  • 205.235.1318 Boehringer Ingelheim Investigational Site

    Debrecen

  • 205.235.1314 Boehringer Ingelheim Investigational Site

    Deszk

  • 205.235.1306 Boehringer Ingelheim Investigational Site

    Érd

  • 205.235.1315 Boehringer Ingelheim Investigational Site

    Farkasgyepü

  • 205.235.1320 Boehringer Ingelheim Investigational Site

    Gyula

  • 205.235.1307 Boehringer Ingelheim Investigational Site

    Kiskunhalas

  • 205.235.1304 Boehringer Ingelheim Investigational Site

    Miskolc

  • 205.235.1317 Boehringer Ingelheim Investigational Site

    Mosonmagyaróvár

  • 205.235.1301 Boehringer Ingelheim Investigational Site

    Pécs

  • 205.235.1313 Boehringer Ingelheim Investigational Site

    Solymár

  • 205.235.1305 Boehringer Ingelheim Investigational Site

    Sopron

  • 205.235.1319 Boehringer Ingelheim Investigational Site

    Szombathely

  • 205.235.1302 Boehringer Ingelheim Investigational Site

    Tatabánya

  • 205.235.1316 Boehringer Ingelheim Investigational Site

    Törökbálint

  • 205.235.1312 Boehringer Ingelheim Investigational Site

    Veszprém

Other trials in Hungary

France17 sites

  • 205.235.1004 Clinique Toulouse Lautrec

    Albi

  • 205.235.1007 Cabinet Médical

    Albi

  • 205.235.1015 Centre Hospitalier

    Barbezieux-Saint-Hilaire

  • 205.235.1012 Cabinet Médical

    Bourges

  • 205.235.1024 Cabinet Médical

    Chamalières

  • 205.235.1006 Centre Hospitalier de Chauny

    Chauny

  • 205.235.1005 Polyclinique

    Cholet

  • 205.235.1013 Cabinet Médical

    La Teste-de-Buch

  • 205.235.1020 Cabinet Médical

    Marseille

  • 205.235.1023 Cabinet Médical

    Montauban

  • 205.235.1025 Centre Médical Erdre Saint Augustin

    Nantes

  • 205.235.1002 Cabinet médical

    Nice

  • 205.235.1001 Hôpital Bichat

    Paris

  • 205.235.1016 Cabinet Médical

    Provins

  • 205.235.1019 Cabinet Médical

    Strasbourg

  • 205.235.1009 Centre Hospitalier de Bigorre

    Tarbes

  • 205.235.1021 Clinique Pasteur

    Toulouse

Other trials in France

United Kingdom15 sites

  • 205.235.3615 Boehringer Ingelheim Investigational Site

    Aberdeen

  • 205.235.3611 Boehringer Ingelheim Investigational Site

    Chertsey

  • 205.235.3613 Boehringer Ingelheim Investigational Site

    Chesterfield

  • 205.235.3608 Boehringer Ingelheim Investigational Site

    Cottingham, Hull

  • 205.235.3605 Boehringer Ingelheim Investigational Site

    Exeter

  • 205.235.3602 Boehringer Ingelheim Investigational Site

    Glasgow

  • 205.235.3610 Boehringer Ingelheim Investigational Site

    Leeds

  • 205.235.3607 Boehringer Ingelheim Investigational Site

    Leicester

  • 205.235.3604 Boehringer Ingelheim Investigational Site

    Middleton

  • 205.235.3612 Boehringer Ingelheim Investigational Site

    Nottingham

  • 205.235.3616 Boehringer Ingelheim Investigational Site

    Paisley

  • 205.235.3614 Boehringer Ingelheim Investigational Site

    Penarth

  • 205.235.3603 Boehringer Ingelheim Investigational Site

    Plymouth

  • 205.235.3609 Boehringer Ingelheim Investigational Site

    Sheffield

  • 205.235.3601 Boehringer Ingelheim Investigational Site

    Solihull, Birmingham

Other trials in United Kingdom

Brazil14 sites

  • 205.235.510 Servico de Pneumologia

    Florianópolis - SC

  • 205.235.508

    Juiz de Fora - MG

  • 205.235.501

    Porto Alegre - RS

  • 205.235.503

    Porto Alegre - RS

  • 205.235.506

    Porto Alegre - RS

  • 205.235.507 Depto.de Medicina Interna-Servico de pneumologia

    Porto Alegre - RS

  • 205.235.502

    Rio de Janeiro - RJ

  • 205.235.505 Dep.Medicina Especializada (DEMESP)

    Rio de Janeiro - RJ

  • 205.235.511 Departamento de Pneumologia

    Salvador - BA

  • 205.235.504 ANEXO 2-Laboratório de Funcao Pulmonar

    Santo André - SP

  • 205.235.512

    São Paulo - SP

  • 205.235.513

    São Paulo - SP

  • 205.235.514 Unidade de Coracao e Pulmao do Dto. de Medicina

    São Paulo - SP

  • 205.235.515 Lar Escola São Francisco / Setor de Pneumologia

    São Paulo - SP

Other trials in Brazil

Germany14 sites

  • 205.235.1113 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.235.1114 Boehringer Ingelheim Investigational Site

    Berlin

  • 205.235.1103 Boehringer Ingelheim Investigational Site

    Brake

  • 205.235.1105 Boehringer Ingelheim Investigational Site

    Braunschweig

  • 205.235.1104 Boehringer Ingelheim Investigational Site

    Bruchsal

  • 205.235.1115 Boehringer Ingelheim Investigational Site

    Hanover

  • 205.235.1109 Boehringer Ingelheim Investigational Site

    Kaufbeuren

  • 205.235.1108 Boehringer Ingelheim Investigational Site

    Loerrach

  • 205.235.1102 Boehringer Ingelheim Investigational Site

    Lübeck

  • 205.235.1106 Boehringer Ingelheim Investigational Site

    München

  • 205.235.1110 Boehringer Ingelheim Investigational Site

    München

  • 205.235.1101 Boehringer Ingelheim Investigational Site

    Ulm

  • 205.235.1107 Boehringer Ingelheim Investigational Site

    Weyhe

  • 205.235.1112 Boehringer Ingelheim Investigational Site

    Wiesloch

Other trials in Germany

Netherlands13 sites

  • 205.235.2110 Poli Longziekten

    Almelo

  • 205.235.2105 Lokatie De Lichtenberg

    Amersfoort

  • 205.235.2107 Poli Longziekten

    Delft

  • 205.235.2106 Lokatie Dordwijk

    Dordrecht

  • 205.235.2104 Poli longziekten

    Eindhoven

  • 205.235.2102 Martini Ziekenhuis Groningen

    Groningen

  • 205.235.2112 Poli Longziekten

    Harderwijk

  • 205.235.2115 Poli Longziekten

    Heerenveen

  • 205.235.2101 Atrium medisch centrum

    Heerlen

  • 205.235.2114 Poli Longziekten

    Hengelo

  • 205.235.2108 Poli Longziekten

    Leeuwarden

  • 205.235.2109 Poli Longziekten

    Rotterdam

  • 205.235.2111 Antonius Ziekenhuis

    Sneek

Other trials in Netherlands

Japan12 sites

  • 205.235.1706 Juntendo University Hospital

    Bunkyo-ku, Tokyo

  • 205.235.1705 Kameda Medical Center

    Kamogawa, Chiba

  • 205.235.1713 Komaki City Hospital

    Komaki, Aichi

  • 205.235.1712 Kurume University Hospital

    Kurume, Fukuoka

  • 205.235.1708 Shinshu University

    Matsumoto, Nagano

  • 205.235.1702 Iwate Medical University Hospital

    Morioka, Iwate

  • 205.235.1710 Osaka City University Hospital

    Osaka, Osaka

  • 205.235.1711 Kinki University Hospital

    Osakasayama, Osaka

  • 205.235.1701 Hokkaido University

    Sapporo, Hokkaido

  • 205.235.1703 Tohoku University Hospital

    Sendai, Miyagi

  • 205.235.1709 Tosei General Hospital

    Seto, Aichi

  • 205.235.1704 Hiraka General Hospital

    Yokote, Akita

Other trials in Japan

Turkey (Türkiye)12 sites

  • 205.235.3510 Cukurova Tip Fakultesi Balcali Hastanesi

    Adana

  • 205.235.3506 Hacettepe Tip Fakultesi

    Ankara

  • 205.235.3507 Ankara SSK Diskapi Egitim Hastanesi

    Ankara

  • 205.235.3508 Atatürk Gögüs Hastaliklari ve Gögüs Cerrahi

    Ankara

  • 205.235.3509 Atatürk Üniversitesi Tip Fakultesi Aziziye

    Erzurum

  • 205.235.3511 Osmangazi Universitesi Tip Fakültesi

    Eskişehir

  • 205.235.3501 Istanbul Universitesi Cerrahpasa Tip Fakultesi

    Istanbul

  • 205.235.3502 Yedikule Gögüs Hastaliklari Hastanesi

    Istanbul

  • 205.235.3503 Tophanelioglu Cad. No: 13/15

    Istanbul

  • 205.235.3504 Cevizli E5 Karayolu

    Istanbul

  • 205.235.3505 Istanbul Universitesi Tip Fakültesi

    Istanbul

  • 205.235.3512 DokuzEylül Universitesi Tip Fakultesi Gögüs Hastaliklari ABD

    Izmir

Other trials in Turkey (Türkiye)

Argentina11 sites

  • 205.235.101

    Buenos Aires

  • 205.235.101 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 205.235.103 Hospital Alemán

    Capital Federal

  • 205.235.104 Hospital de Clinicas José de San Martín

    Capital Federal

  • 205.235.105 Hospital General de Agudos José María Ramos Mejía

    Capital Federal

  • 205.235.107 Policlínica Bancaria

    Capital Federal

  • 205.235.108 Hospital General de Agudos Dr. Enrique Tornú

    Capital Federal

  • 205.235.109 Hospital Muñiz

    Capital Federal

  • 205.235.110 Hospital Privado - Centro Médico de Córdoba S.A.

    Parque Velez Sarlfield

  • 205.235.102 Instituto Cardiovascular de Rosario

    Rosario

  • 205.235.106 Hospital Cetrángolo

    Vicente López

Other trials in Argentina

South Africa11 sites

  • 205.235.2908

    Bloemfontein

  • 205.235.2910

    Cape Town

  • 205.235.2912

    Cape Town

  • 205.235.2904

    Durban

  • 205.235.2911

    Durban

  • 205.235.2902

    George

  • 205.235.2905

    Paarl

  • 205.235.2901 Boehringer Ingelheim Investigational Site

    Pretoria

  • 205.235.2906

    Somerset West

  • 205.235.2903

    Vanderbijlpark

  • 205.235.2909

    Welkom

Other trials in South Africa

Greece10 sites

  • 205.235.1202 8th Pulmonology Clinic "Sotiria" Athens Chest Hospital

    Athens

  • 205.235.1203 Boehringer Ingelheim Investigational Site

    Athens

  • 205.235.1201 Boehringer Ingelheim Investigational Site

    Heraklion

  • 205.235.1211 Boehringer Ingelheim Investigational Site

    Kavala

  • 205.235.1204 Boehringer Ingelheim Investigational Site

    Larissa

  • 205.235.1209 Boehringer Ingelheim Investigational Site

    Pátrai

  • 205.235.1210 Boehringer Ingelheim Investigational Site

    Pátrai

  • 205.235.1205 Boehringer Ingelheim Investigational Site

    Thessaloniki

  • 205.235.1206 Boehringer Ingelheim Investigational Site

    Thessaloniki

  • 205.235.1207 Boehringer Ingelheim Investigational Site

    Thessaloniki

Other trials in Greece

Poland10 sites

  • 205.235.2410 Boehringer Ingelheim Investigational Site

    Gdansk

  • 205.235.2407 Boehringer Ingelheim Investigational Site

    Katowice

  • 205.235.2408 Boehringer Ingelheim Investigational Site

    Krakow

  • 205.235.2405 Boehringer Ingelheim Investigational Site

    Lodz

  • 205.235.2409 Boehringer Ingelheim Investigational Site

    Lodz

  • 205.235.2401 Boehringer Ingelheim Investigational Site

    Warsaw

  • 205.235.2402 Boehringer Ingelheim Investigational Site

    Warsaw

  • 205.235.2403 Boehringer Ingelheim Investigational Site

    Warsaw

  • 205.235.2404 Boehringer Ingelheim Investigational Site

    Wroclaw

  • 205.235.2406 Boehringer Ingelheim Investigational Site

    Zabrze

Other trials in Poland

Australia8 sites

  • 205.235.0205 Boehringer Ingelheim Investigational Site

    Bankstown, New South Wales

  • 205.235.0206 Boehringer Ingelheim Investigational Site

    Box Hill, Victoria

  • 205.235.0204 Boehringer Ingelheim Investigational Site

    Cairns, Queensland

  • 205.235.0202 Boehringer Ingelheim Investigational Site

    Concord, New South Wales

  • 205.235.0201 Boehringer Ingelheim Investigational Site

    Geelong, Victoria

  • 205.235.0207 Boehringer Ingelheim Investigational Site

    Port Lincoln, South Australia

  • 205.235.0203 Boehringer Ingelheim Investigational Site

    Redcliffe, Queensland

  • 205.235.0209 Boehringer Ingelheim Investigational Site

    Westmead, New South Wales

Other trials in Australia

Mexico7 sites

  • 205.235.2004 Edif. Dr. Rodrigo F. Barragan, P.B.

    Col. Mitras Centro, Monterrey, N.L.

  • 205.235.2002

    Guadalajara, Jal.

  • 205.235.2005

    Mexico City

  • 205.235.2006 Tlalpan 4000, Pabellón 5, EPOC

    Mexico City

  • 205.235.2009

    Puebla City

  • 205.235.2010 Depto. De Ivestigación

    Toluca

  • 205.235.2003

    Zapopan, Jalisco

Other trials in Mexico

Switzerland7 sites

  • 205.235.3202 Boehringer Ingelheim Investigational Site

    Basel

  • 205.235.3203 Universitätsspital Basel

    Basel

  • 205.235.3204 Boehringer Ingelheim Investigational Site

    Faltigberg

  • 205.235.3205 Boehringer Ingelheim Investigational Site

    Lugano

  • 205.235.3206 Boehringer Ingelheim Investigational Site

    Montana

  • 205.235.3208 Boehringer Ingelheim Investigational Site

    Winterthur

  • 205.235.3201 Boehringer Ingelheim Investigational Site

    Zurich

Other trials in Switzerland

Austria5 sites

  • 205.235.0303 Boehringer Ingelheim Investigational Site

    Graz

  • 205.235.0305 Boehringer Ingelheim Investigational Site

    Innsbruck

  • 205.235.0304 Boehringer Ingelheim Investigational Site

    Leoben

  • 205.235.0301 Boehringer Ingelheim Investigational Site

    Vienna

  • 205.235.0302 Boehringer Ingelheim Investigational Site

    Vienna

Other trials in Austria

Finland5 sites

  • 205.235.0903 Boehringer Ingelheim Investigational Site

    Helsinki

  • 205.235.0901 Boehringer Ingelheim Investigational Site

    Jyväskylä

  • 205.235.0905 Boehringer Ingelheim Investigational Site

    Kotka

  • 205.235.0904 Boehringer Ingelheim Investigational Site

    Lahti

  • 205.235.0902 Boehringer Ingelheim Investigational Site

    Pori

Other trials in Finland

Philippines5 sites

  • 205.235.2301 Philippine General Hospital

    Manila

  • 205.235.2305 University of Santo Tomas Hospital

    Manila

  • 205.235.2302 Philippine Heart Center

    Quezon City

  • 205.235.2303 Veterans Memorial Medical Center

    Quezon City

  • 205.235.2304 Lung Center of the Philippines

    Quezon City

Other trials in Philippines

Portugal5 sites

  • 205.235.2504 Centro Hospitalar de Coimbra

    Coimbra

  • 205.235.2503 Hospital Pulido Valente

    Lisbon

  • 205.235.2505 Hospital de Santa Marta

    Lisbon

  • 205.235.2501 Hospital de São João

    Porto

  • 205.235.2502 Centro Hospitalar de Vila Nova de Gaia

    Vila Nova de Gaia

Other trials in Portugal

Russia5 sites

  • 205.235.2601 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.235.2602 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.235.2603 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.235.2605 Boehringer Ingelheim Investigational Site

    Moscow

  • 205.235.2604 Boehringer Ingelheim Investigational Site

    Saint Petersburg

Other trials in Russia

Slovakia5 sites

  • 205.235.2701 Boehringer Ingelheim Investigational Site

    Bratislava

  • 205.235.2702 Boehringer Ingelheim Investigational Site

    Bratislava

  • 205.235.2703 Boehringer Ingelheim Investigational Site

    Martin

  • 205.235.2704 Boehringer Ingelheim Investigational Site

    Poprad

  • 205.235.2705 Boehringer Ingelheim Investigational Site

    Topoľčany

Other trials in Slovakia

Slovenia5 sites

  • 205.235.2801 Boehringer Ingelheim Investigational Site

    Golnik

  • 205.235.2802 Boehringer Ingelheim Investigational Site

    Golnik

  • 205.235.2805 Boehringer Ingelheim Investigational Site

    Kamnik

  • 205.235.2803 Boehringer Ingelheim Investigational Site

    Ljubljana

  • 205.235.2804 Boehringer Ingelheim Investigational Site

    Topolšica

Other trials in Slovenia

Thailand5 sites

  • 205.235.3402 Boehringer Ingelheim Investigational Site

    Bangkok

  • 205.235.3403 Boehringer Ingelheim Investigational Site

    Bangkok

  • 205.235.3404 Boehringer Ingelheim Investigational Site

    Bangkok

  • 205.235.3401 Boehringer Ingelheim Investigational Site

    Chiang Mai

  • 205.235.3405 Boehringer Ingelheim Investigational Site

    Khon Kaen

Other trials in Thailand

Hong Kong4 sites

  • 205.235.1401 Boehringer Ingelheim Investigational Site

    Hong Kong

  • 205.235.1403 Boehringer Ingelheim Investigational Site

    Hong Kong

  • 205.235.1402 Boehringer Ingelheim Investigational Site

    Kowloon

  • 205.235.1404 Boehringer Ingelheim Investigational Site

    Kowloon

Other trials in Hong Kong

Norway4 sites

  • 205.235.2202 Boehringer Ingelheim Investigational Site

    Arendal

  • 205.235.2201 Boehringer Ingelheim Investigational Site

    Fredrikstad

  • 205.235.2205 Boehringer Ingelheim Investigational Site

    Sandvika

  • 205.235.2204 Boehringer Ingelheim Investigational Site

    Straume

Other trials in Norway

Ireland3 sites

  • 205.235.1501 Boehringer Ingelheim Investigational Site

    Dublin

  • 205.235.1503 Boehringer Ingelheim Investigational Site

    Dublin

  • 205.235.1505 Boehringer Ingelheim Investigational Site

    Dublin

Other trials in Ireland

Lithuania3 sites

  • 205.235.1801 Boehringer Ingelheim Investigational Site

    Kaunas

  • 205.235.1802 Boehringer Ingelheim Investigational Site

    Kaunas

  • 205.235.1803 Boehringer Ingelheim Investigational Site

    Vilnius

Other trials in Lithuania

Malaysia3 sites

  • 205.235.1901 Boehringer Ingelheim Investigational Site

    Kuala Lumpur

  • 205.235.1902 Boehringer Ingelheim Investigational Site

    Kuala Lumpur

  • 205.235.1903 Boehringer Ingelheim Investigational Site

    Kuala Lumpur

Other trials in Malaysia

Singapore3 sites

  • 205.235.1904 Boehringer Ingelheim Investigational Site

    Singapore

  • 205.235.1905 Boehringer Ingelheim Investigational Site

    Singapore

  • 205.235.1906 Boehringer Ingelheim Investigational Site

    Singapore

Other trials in Singapore

Taiwan3 sites

  • 205.235.3301 Boehringer Ingelheim Investigational Site

    Taipei

  • 205.235.3302 Boehringer Ingelheim Investigational Site

    Taipei

  • 205.235.3303 Boehringer Ingelheim Investigational Site

    Taipei

Other trials in Taiwan

New Zealand2 sites

  • 205.235.0211 Boehringer Ingelheim Investigational Site

    Auckland

  • 205.235.0212 Boehringer Ingelheim Investigational Site

    Christchurch, New Zealand

Other trials in New Zealand

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).

The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.

Being tested
tiotropium, placebo
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.

  • tiotropiumDrug

  • placeboDrug

What is being measured

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

  1. Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years

    Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.

    Measured: From day 30 to 4 years

  2. Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years

    Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.

    Measured: From day 30 to 4 years

Secondary outcomes (85)

  1. Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment

    Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1

    Measured: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.

  2. Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment

    Rate of decline of forced expiratory volume in one second (FEV1) measured after the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1

    Measured: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days

  3. Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years

    Rate of decline of forced vital capacity (FVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

    Measured: From day 30 to 4 years

  4. Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years

    Rate of decline of forced vital capacity (FVC) measured after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

    Measured: From day 30 to 4 years

  5. Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years

    Rate of decline of slow vital capacity (SVC) measured before the use of bronchodilators. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

    Measured: From day 30 to 4 years

  6. Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years

    Rate of decline of slow vital capacity (SVC) measured after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

    Measured: From day 30 to 4 years

  7. Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score

    SGRQ total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). A negative rate of decline shows decreasing SGRQ total score (or improved health) over time, while a positive value shows increasing score (or worsen health).

    Measured: From month 6 to 4 years

  8. Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment

    Rate of decline of forced vital capacity (FVC) before bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

    Measured: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.

  9. Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment

    Rate of decline of forced vital capacity (FVC) after bronchodilation. A negative rate of decline indicates decreasing FVC over time, while a positive value indicates increasing FVC

    Measured: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days

  10. Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment

    Rate of decline slow vital capacity (SVC) before bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

    Measured: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days

  11. Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment

    Rate of decline of slow vital capacity (SVC) after bronchodilation. A negative rate of decline indicates decreasing SVC over time, while a positive value indicates increasing SVC

    Measured: Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days

  12. Time to First Exacerbation

    Chronic obstructive pulmonary disease (COPD) exacerbation

    Measured: From Day 1 to 4 years

  13. Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year

    Measured: Day 1 to 4 years

  14. Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

    Measured: Day 1 to 4 years

  15. Number of Exacerbation Days Per Patient Year

    Number of exacerbation days normalized by treatment exposure

    Measured: Day 1 to 4 years

  16. Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)

    Measured: Day 1 to 4 years

  17. Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization

    Measured: From Day 1 to 4 years

  18. Number of Exacerbation Leading to Hospitalization

    Estimated number of exacerbations leading to hospitalizations per patient year

    Measured: From Day 1 to 4 years

  19. Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization

    Number of days with chronic obstructive pulmonary disease (COPD) exacerbation leading to hospitalization (normalized by treatment exposure)

    Measured: From Day 1 to 4 years

  20. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1

    Estimated FEV1 before bronchodilator at Month 1

    Measured: Month 1

  21. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1

    Estimated forced expiratory volume in one second (FEV1) after bronchodilator at month 1

    Measured: Month 1

  22. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6

    Estimated forced expiratory volume in one second (FEV1) before bronchodilator at month 6

    Measured: Month 6

  23. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6

    Measured: Month 6

  24. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12

    Measured: Month 12

  25. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12

    Measured: Month 12

  26. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18

    Measured: Month 18

  27. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18

    Measured: Month 18

  28. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24

    Measured: Month 24

  29. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24

    Measured: Month 24

  30. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30

    Measured: Month 30

  31. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30

    Measured: Month 30

  32. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36

    Measured: Month 36

  33. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36

    Measured: Month 36

  34. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42

    Measured: Month 42

  35. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42

    Estimated FEV1 after bronchodilator at Month 42

    Measured: Month 42

  36. Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48

    Measured: Month 48

  37. Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48

    Measured: Month 48

  38. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1

    Measured: Month 1

  39. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1

    Measured: Month 1

  40. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6

    Measured: Month 6

  41. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6

    Measured: Month 6

  42. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12

    Measured: Month 12

  43. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12

    Measured: Month 12

  44. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18

    Measured: Month 18

  45. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18

    Measured: Month 18

  46. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24

    Measured: Month 24

  47. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24

    Measured: Month 24

  48. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30

    Measured: Month 30

  49. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30

    Measured: Month 30

  50. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36

    Measured: Month 36

  51. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36

    Measured: Month 36

  52. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42

    Measured: Month 42

  53. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42

    Measured: Month 42

  54. Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48

    Measured: Month 48

  55. Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48

    Measured: Month 48

  56. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1

    Measured: Month 1

  57. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1

    Measured: Month 1

  58. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6

    Measured: Month 6

  59. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6

    Measured: Month 6

  60. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12

    Measured: Month 12

  61. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12

    Measured: Month 12

  62. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18

    Measured: Month 18

  63. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18

    Measured: Month 18

  64. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24

    Measured: Month 24

  65. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24

    Measured: Month 24

  66. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30

    Measured: Month 30

  67. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30

    Measured: Month 30

  68. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36

    Measured: Month 36

  69. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36

    Measured: Month 36

  70. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42

    Measured: Month 42

  71. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42

    Measured: Month 42

  72. Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48

    Measured: Month 48

  73. Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48

    Measured: Month 48

  74. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

    Measured: Month 6

  75. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

    Measured: Month 12

  76. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

    Measured: Month 18

  77. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

    Measured: Month 24

  78. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

    Measured: Month 30

  79. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

    Measured: Month 36

  80. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

    Measured: Month 42

  81. Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48

    • SGRQ total score summarizes the impact of COPD on overall patient's health status.
    • Total scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
    • The scale is continuous.
    • Rate of decline shows the yearly change of SGRQ total score.

    Measured: Month 48

  82. Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)

    On-treatment defined as day 1 to completion of double blinded treatment plus 30 days

    Measured: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days

  83. Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)

    All cause mortality vital status information was followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used.

    Measured: Day 1 to day 1470

  84. Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)

    The primary cause of death was adjudicated by an external committee prior to unblinding; on-treatment defined as day 1 to completion of double blinded treatment plus 30 days

    Measured: Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days

  85. Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)

    The primary cause of death was adjudicated by an external committee prior to unblinding; vital status was information followed-up after discontinuation; vital status information up to 1470 days after the start of treatment was used

    Measured: Day 1 to day 1470

Timeline

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

  1. First posted5 Sep 2005 (estimated)
  2. Study startDec 2002
  3. Primary completionFeb 2008

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 3
Primary purpose
Treatment
Intervention model
Parallel groups
Enrolment
5,993 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00144339
Sponsor's protocol ID
205.235
Status last verified
Apr 2014
First submitted
2 Sep 2005
Last updated
20 May 2014

Publications

  • Rabe KF, Halpin DMG, Han MK, Miravitlles M, Singh D, Gronke L, Voss F, Martinez FJ. Composite endpoints in COPD: clinically important deterioration in the UPLIFT trial. Respir Res. 2020 Jul 9;21(1):177. doi: 10.1186/s12931-020-01431-y.

    PubMed 32646424

  • Tashkin DP, Miravitlles M, Celli BR, Metzdorf N, Mueller A, Halpin DMG, Anzueto A. Concomitant inhaled corticosteroid use and the risk of pneumonia in COPD: a matched-subgroup post hoc analysis of the UPLIFT(R) trial. Respir Res. 2018 Oct 5;19(1):196. doi: 10.1186/s12931-018-0874-0.

    PubMed 30290801

  • Celli BR, Decramer M, Liu D, Metzdorf N, Asijee GM, Tashkin DP. Defining a COPD composite safety endpoint for demonstrating efficacy in clinical trials: results from the randomized, placebo-controlled UPLIFT(R) trial. Respir Res. 2016 May 4;17(1):48. doi: 10.1186/s12931-016-0361-4.

    PubMed 27141828

  • Goossens LM, Leimer I, Metzdorf N, Becker K, Rutten-van Molken MP. Does the 2013 GOLD classification improve the ability to predict lung function decline, exacerbations and mortality: a post-hoc analysis of the 4-year UPLIFT trial. BMC Pulm Med. 2014 Oct 18;14:163. doi: 10.1186/1471-2466-14-163.

    PubMed 25326750

  • Tashkin DP, Li N, Kleerup EC, Halpin D, Celli B, Decramer M, Elashoff R. Acute bronchodilator responses decline progressively over 4 years in patients with moderate to very severe COPD. Respir Res. 2014 Aug 31;15(1):102. doi: 10.1186/s12931-014-0102-5.

    PubMed 25175805

  • Janssens W, Liu Y, Liu D, Kesten S, Tashkin DP, Celli BR, Decramer M. Quality and reproducibility of spirometry in COPD patients in a randomized trial (UPLIFT(R)). Respir Med. 2013 Sep;107(9):1409-16. doi: 10.1016/j.rmed.2013.04.015. Epub 2013 May 25.

    PubMed 23714653

  • Tashkin DP, Celli BR, Decramer M, Lystig T, Liu D, Kesten S. Efficacy of tiotropium in COPD patients with FEV1 >/= 60% participating in the UPLIFT(R) trial. COPD. 2012 Jun;9(3):289-96. doi: 10.3109/15412555.2012.656211. Epub 2012 Mar 20.

    PubMed 22432932

  • Kesten S, Celli B, Decramer M, Liu D, Tashkin D. Adverse health consequences in COPD patients with rapid decline in FEV1--evidence from the UPLIFT trial. Respir Res. 2011 Sep 28;12(1):129. doi: 10.1186/1465-9921-12-129.

    PubMed 21955733

  • Tashkin D, Celli B, Kesten S, Lystig T, Decramer M. Effect of tiotropium in men and women with COPD: results of the 4-year UPLIFT trial. Respir Med. 2010 Oct;104(10):1495-504. doi: 10.1016/j.rmed.2010.03.033. Epub 2010 Apr 24.

    PubMed 20418083

  • Troosters T, Celli B, Lystig T, Kesten S, Mehra S, Tashkin DP, Decramer M; Uplift Investigators. Tiotropium as a first maintenance drug in COPD: secondary analysis of the UPLIFT trial. Eur Respir J. 2010 Jul;36(1):65-73. doi: 10.1183/09031936.00127809. Epub 2010 Feb 25.

    PubMed 20185426

  • Decramer M, Celli B, Kesten S, Lystig T, Mehra S, Tashkin DP; UPLIFT investigators. Effect of tiotropium on outcomes in patients with moderate chronic obstructive pulmonary disease (UPLIFT): a prespecified subgroup analysis of a randomised controlled trial. Lancet. 2009 Oct 3;374(9696):1171-8. doi: 10.1016/S0140-6736(09)61298-8. Epub 2009 Aug 27.

    PubMed 19716598

  • Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, Decramer M; UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008 Oct 9;359(15):1543-54. doi: 10.1056/NEJMoa0805800. Epub 2008 Oct 5.

    PubMed 18836213

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 490 sites in 37 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 4 inclusion and 15 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 490 sites in United States, Spain, Italy, Denmark, Belgium and 32 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Aug 2009). 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?

Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years (time frame: From day 30 to 4 years). The study lists 2 primary outcomes in all. 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 NCT00144339, which also lists 12 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 20 May 2014.

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