Pulmonary Disease, Chronic ObstructivePhase 3NCT00274573

Effects of Once Daily Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity

A Phase 3 study testing Tiotropium bromide in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 177 sites in Germany.

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

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Tiotropium bromide
How many people: 1,639 participants
Where: 177 sitesGermany
Study dates: Mar 2002to Oct 2002
Phase: Phase 3
Are there results?: None posted in the registry

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 and must meet the following spirometric criteria:
Patients must have relatively stable, mild to severe airway obstruction with an FEV1 =<70% of predicted normal and an FEV1/FVC < 70 %.
Predicted normal values will be taken from the print-outs of the spirometers. Spirometers have to calibrated according to ECCS.
Male or female patients 40 years of age or older.
Patients must be current or ex-smokers with a smoking history of 10 or more than 10 pack-years. Pack Years = Number of cigarettes/day : 20 x years of smoking (Patients who have never smoked cigarettes must not be included)
Patients must be able to perform all study related tests, acceptable pulmonary function tests, including Peak Expiratory Flow Rate (PEFR) measurements, and must be able to maintain diary cards during the study period as required in the protocol.
Patients must be able to inhale medication from the HandiHaler.
All patients must sign an Informed Consent Form prior to participation in the trial i.e. prior to pre-study washout of their usual pulmonary medications.

Who cannot join

Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
Patients with a recent history (i.e., one year or less) of myocardial infarction.
Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years.
Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy.
Patients with known active tuberculosis.
Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.

Show all 18Show fewer

Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1.
Patients with any respiratory infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period.
Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six week prior to the Screening Visit (Visit 1).
Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
Patients with known symptomatic prostate hypertrophy or bladder neck obstruction.
Patients with known narrow-angle glaucoma.
Patients using oral corticosteroid medication at unstable doses (i.e., less than four weeks on a stable dose before Visit 1) or at doses in excess of the equivalent of 10 mg of 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).
Patients with a history of asthma, allergic rhinitis or atopy.
Patients with a history of and/or active significant alcohol or drug abuse.
Patients who have taken an investigational drug within one month prior to Screening Visit (Visit 1). A log of all subjects screened, and reasons for exclusion for those not randomised will be maintained.

Trial locations and contacts

177 sites in 1 country.

City, postcode or hospital

177 sites in 1 country

Germany177 sites

Boehringer Ingelheim Investigational Site
Aachen
Boehringer Ingelheim Investigational Site
Ahrensburg
Boehringer Ingelheim Investigational Site
Altenburg
Boehringer Ingelheim Investigational Site
Amberg
Boehringer Ingelheim Investigational Site
Aschaffenburg
Boehringer Ingelheim Investigational Site
Aue
Boehringer Ingelheim Investigational Site
Auerbach
Boehringer Ingelheim Investigational Site
Augsburg
Boehringer Ingelheim Investigational Site
Backnang
Boehringer Ingelheim Investigational Site
Bad Kissingen
Boehringer Ingelheim Investigational Site
Bad Krozingen
Boehringer Ingelheim Investigational Site
Bad Lippspringe
Boehringer Ingelheim Investigational Site
Bad Nauheim
Boehringer Ingelheim Investigational Site
Bad Neustadt an der Saale
Boehringer Ingelheim Investigational Site
Bad Soden
Boehringer Ingelheim Investigational Site
Baunatal
Boehringer Ingelheim Investigational Site
Beckum
Boehringer Ingelheim Investigational Site
Bensheim
Boehringer Ingelheim Investigational Site
Berlin
MEDARS GmbH
Berlin
Boehringer Ingelheim Investigational Site
Bernau
Boehringer Ingelheim Investigational Site
Bielefeld
Boehringer Ingelheim Investigational Site
Bochum
Boehringer Ingelheim Investigational Site
Bonn
Boehringer Ingelheim Investigational Site
Brake
Boehringer Ingelheim Investigational Site
Brandenburg
Boehringer Ingelheim Investigational Site
Braunschweig
Boehringer Ingelheim Investigational Site
Bruchsal
Boehringer Ingelheim Investigational Site
Buchholz
Boehringer Ingelheim Investigational Site
Celle
Boehringer Ingelheim Investigational Site
Chemnitz
Boehringer Ingelheim Investigational Site
Cloppenburg
Boehringer Ingelheim Investigational Site
Coburg
Boehringer Ingelheim Investigational Site
Cologne
Boehringer Ingelheim Investigational Site
Dachau
Boehringer Ingelheim Investigational Site
Darmstadt
Boehringer Ingelheim Investigational Site
Deggendorf
Boehringer Ingelheim Investigational Site
Delmenhorst
Boehringer Ingelheim Investigational Site
Detmold
Boehringer Ingelheim Investigational Site
Dillingen
Boehringer Ingelheim Investigational Site
Dinslaken
Boehringer Ingelheim Investigational Site
Dortmund
Boehringer Ingelheim Investigational Site
Dresden
Boehringer Ingelheim Investigational Site
Duisburg
Boehringer Ingelheim Investigational Site
Dülmen
Boehringer Ingelheim Investigational Site
Düren
Boehringer Ingelheim Investigational Site
Düsseldorf
Boehringer Ingelheim Investigational Site
Eggenfelden
Boehringer Ingelheim Investigational Site
Eisenach
Boehringer Ingelheim Investigational Site
Eisenhüttenstadt
Boehringer Ingelheim Investigational Site
Emden
Boehringer Ingelheim Investigational Site
Erfurt
Boehringer Ingelheim Investigational Site
Erlangen
Boehringer Ingelheim Investigational Site
Essen
Boehringer Ingelheim Investigational Site
Euskirchen
Boehringer Ingelheim Investigational Site
Fellbach
Boehringer Ingelheim Investigational Site
Fluda
Boehringer Ingelheim Investigational Site
Frankenthal
Boehringer Ingelheim Investigational Site
Frankfurt
Boehringer Ingelheim Investigational Site
Frankfurt (Oder)
Boehringer Ingelheim Investigational Site
Frankfurt am Main
Boehringer Ingelheim Investigational Site
Freising
Boehringer Ingelheim Investigational Site
Fulda
Boehringer Ingelheim Investigational Site
Fürstenfeldbruck
Boehringer Ingelheim Investigational Site
Fürstenwalde
Boehringer Ingelheim Investigational Site
Fürth
Boehringer Ingelheim Investigational Site
Garmisch-Partenkirchen
Boehringer Ingelheim Investigational Site
Gelsenkirchen
Boehringer Ingelheim Investigational Site
Germering
Boehringer Ingelheim Investigational Site
Goch
Boehringer Ingelheim Investigational Site
Göppingen
Boehringer Ingelheim Investigational Site
Greiz
Boehringer Ingelheim Investigational Site
Groß Gaglow
Boehringer Ingelheim Investigational Site
Großenhain
Boehringer Ingelheim Investigational Site
Gütersloh
Boehringer Ingelheim Investigational Site
Hagen
Boehringer Ingelheim Investigational Site
Hamburg
Boehringer Ingelheim Investigational Site
Hamm
Boehringer Ingelheim Investigational Site
Hanover
Boehringer Ingelheim Investigational Site
Hartha
Boehringer Ingelheim Investigational Site
Heidelberg
Boehringer Ingelheim Investigational Site
Heidenheim
Boehringer Ingelheim Investigational Site
Heilbronn
Boehringer Ingelheim Investigational Site
Hemmingen
Boehringer Ingelheim Investigational Site
Hildburghausen
Boehringer Ingelheim Investigational Site
Hildesheim
Boehringer Ingelheim Investigational Site
Homburg/Saar
Boehringer Ingelheim Investigational Site
Hoyerswerda
Boehringer Ingelheim Investigational Site
Ingolstadt
Boehringer Ingelheim Investigational Site
Kamen
Boehringer Ingelheim Investigational Site
Karlsruhe
Boehringer Ingelheim Investigational Site
Kaufbeuren
Boehringer Ingelheim Investigational Site
Kempten
Boehringer Ingelheim Investigational Site
Kiel
Boehringer Ingelheim Investigational Site
Koblenz
Boehringer Ingelheim Investigational Site
Köthen
Boehringer Ingelheim Investigational Site
Krefeld
Boehringer Ingelheim Investigational Site
Landshut
Boehringer Ingelheim Investigational Site
Langenhagen
Boehringer Ingelheim Investigational Site
Leipzig
Boehringer Ingelheim Investigational Site
Leonberg
Boehringer Ingelheim Investigational Site
Loerrach
Boehringer Ingelheim Investigational Site
Lübeck
Boehringer Ingelheim Investigational Site
Lüdenscheid
Boehringer Ingelheim Investigational Site
Ludwigsburg
Boehringer Ingelheim Investigational Site
Lüneburg
Boehringer Ingelheim Investigational Site
Magdeburg
Boehringer Ingelheim Investigational Site
Mainz
Johannes-Gutenberg-Universität Mainz
Mainz
Boehringer Ingelheim Investigational Site
Mannheim
Boehringer Ingelheim Investigational Site
Marburg
Boehringer Ingelheim Investigational Site
Markkleeberg
Boehringer Ingelheim Investigational Site
Minden
Boehringer Ingelheim Investigational Site
Mittweida
Boehringer Ingelheim Investigational Site
Moers
Boehringer Ingelheim Investigational Site
Mönchengladbach
Boehringer Ingelheim Investigational Site
Mühlhausen
Boehringer Ingelheim Investigational Site
München
Boehringer Ingelheim Investigational Site
Münster
Boehringer Ingelheim Investigational Site
Neu-Isenburg
Boehringer Ingelheim Investigational Site
Neu-Ulm
Boehringer Ingelheim Investigational Site
Neubrandenburg
Boehringer Ingelheim Investigational Site
Neuss
Boehringer Ingelheim Investigational Site
Neuwied
Boehringer Ingelheim Investigational Site
Niesky
Boehringer Ingelheim Investigational Site
Nordhausen
Boehringer Ingelheim Investigational Site
Nortorf
Boehringer Ingelheim Investigational Site
Oschatz
Boehringer Ingelheim Investigational Site
Oschersleben
Boehringer Ingelheim Investigational Site
Papenburg
Boehringer Ingelheim Investigational Site
Potsdam
Boehringer Ingelheim Investigational Site
Rathenow
Boehringer Ingelheim Investigational Site
Recklinghausen
Boehringer Ingelheim Investigational Site
Regensburg
Boehringer Ingelheim Investigational Site
Rehau
Boehringer Ingelheim Investigational Site
Remscheid
Boehringer Ingelheim Investigational Site
Reutlingen
Boehringer Ingelheim Investigational Site
Rhaunen
Boehringer Ingelheim Investigational Site
Rostock
Boehringer Ingelheim Investigational Site
Rüdersdorf
Boehringer Ingelheim Investigational Site
Rüsselsheim am Main
Boehringer Ingelheim Investigational Site
Saarbrücken
Boehringer Ingelheim Investigational Site
Saarlouis
Boehringer Ingelheim Investigational Site
Saint Ingbert
Boehringer Ingelheim Investigational Site
Schrobenhausen
Boehringer Ingelheim Investigational Site
Schwabach
Boehringer Ingelheim Investigational Site
Schwäbisch Gmünd
Boehringer Ingelheim Investigational Site
Schweinfurt
Boehringer Ingelheim Investigational Site
Schwetzingen
Boehringer Ingelheim Investigational Site
Siegen
Boehringer Ingelheim Investigational Site
Simmern
Boehringer Ingelheim Investigational Site
Sindelfingen
Boehringer Ingelheim Investigational Site
Singen
Boehringer Ingelheim Investigational Site
Solingen
Boehringer Ingelheim Investigational Site
Sonneberg
Boehringer Ingelheim Investigational Site
Stade
Boehringer Ingelheim Investigational Site
Steinhagen
Boehringer Ingelheim Investigational Site
Stolberg
Boehringer Ingelheim Investigational Site
Stuttgart
Boehringer Ingelheim Investigational Site
Teuchern
Boehringer Ingelheim Investigational Site
Ulm
Boehringer Ingelheim Investigational Site
Uttenreuth
Boehringer Ingelheim Investigational Site
Vechta
Boehringer Ingelheim Investigational Site
Velbert
Boehringer Ingelheim Investigational Site
Verden an der Aller
Boehringer Ingelheim Investigational Site
Vöhringen
Boehringer Ingelheim Investigational Site
Waiblingen
Boehringer Ingelheim Investigational Site
Waren
Boehringer Ingelheim Investigational Site
Welzheim
Boehringer Ingelheim Investigational Site
Weyhe
Boehringer Ingelheim Investigational Site
Wiesbaden
Boehringer Ingelheim Investigational Site
Wiesloch
Boehringer Ingelheim Investigational Site
Witten
Boehringer Ingelheim Investigational Site
Wolfsburg
Boehringer Ingelheim Investigational Site
Wuppertal
Boehringer Ingelheim Investigational Site
Zerbst
Boehringer Ingelheim Investigational Site
Zwickau

Other trials in Germany

About this study

Official title: Acute and Long-term Effects of Once Daily Oral Inhalation of Tiotropium 18 Mcg Dry Powder Inhalation Capsules in a Placebo Controlled Parallel Group Design Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity

The primary objective of this study is to investigate the effect of tiotropium vs. placebo on trough FEV1 and FEV1 2 hours post inhalation after 12 weeks of treatment. For both endpoints changes from baseline will be analysed. Three strata of patients will be included (severe COPD, i.e. <35% of predicted FEV1, moderate COPD, i.e. 35% - <50% of predicted FEV1, mild COPD, i.e. 50% - 70% of predicted FEV1, according to American Thoracic Society [ATS] criteria). The study is conducted in order to find out for which endpoint tiotropium is different from placebo in which stratum.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Tiotropium bromide
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

What is being measured

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

Change from baseline in trough FEV1 (Forced expiratory volume in one second)
Measured: after 12 weeks
Change from baseline in FEV1 2 hours post inhalation
Measured: after 12 weeks

Secondary outcomes (9)

Change from baseline in FEV1 2 hours post inhalation
Measured: Day 1
Change from baseline in FVC (Forced Vital Capacity) 2 hours post inhalation
Measured: Day 1 and 85
Change from baseline in IVC (Inspiratory Vital Capacity) 2 hours post inhalation
Measured: Day 1 and 85
Number of patients having a COPD exacerbation
Measured: 12 weeks
Number of patients being hospitalised due to a COPD exacerbation
Measured: 12 weeks
Number of COPD exacerbations per patient
Measured: 12 weeks
Number hospitalisations due to COPD exacerbations per patient
Measured: 12 weeks
Duration of COPD exacerbations per patient
Measured: 12 weeks
Duration of hospitalisations due to a COPD exacerbation
Measured: 12 weeks

Timeline

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

Mar 2002Oct 2002

First posted11 Jan 2006 (estimated)
Study startMar 2002
Primary completionOct 2002

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 1,639 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00274573
Sponsor's protocol ID: 205.257
Status last verified: Nov 2013
First submitted: 9 Jan 2006
Last updated: 21 Nov 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute and Long-term Effects of Once Daily Oral Inhalation of Tiotropium 18 Mcg Dry Powder Inhalation Capsules in a Placebo Controlled Parallel Group Design Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity
ClinicalTrials.gov ID: NCT00274573
Acronym / sponsor ID: 205.257
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,639 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2002
Primary completion: Oct 2002 (actual)
First posted: 11 Jan 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
Male or female patients 40 years of age or older.
Patients must be current or ex-smokers with a smoking history of 10 or more than 10 pack-years. Pack Years = Number of cigarettes/day : 20 x years of smoking (Patients who have never smoked cigarettes must not be included)
Patients must be able to perform all study related tests, acceptable pulmonary function tests, including Peak Expiratory Flow Rate (PEFR) measurements, and must be able to maintain diary cards during the study period as required in the protocol.
Patients must be able to inhale medication from the HandiHaler.

Key exclusion criteria (18 listed)

Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
Patients with a recent history (i.e., one year or less) of myocardial infarction.
Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years.
Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy.
Patients with known active tuberculosis.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tiotropium bromide	Drug	–

Primary outcome

Change from baseline in trough FEV1 (Forced expiratory volume in one second)
Time frame: after 12 weeks
Change from baseline in FEV1 2 hours post inhalation
Time frame: after 12 weeks

9 secondary outcomes

Change from baseline in FEV1 2 hours post inhalation
Time frame: Day 1
Change from baseline in FVC (Forced Vital Capacity) 2 hours post inhalation
Time frame: Day 1 and 85
Change from baseline in IVC (Inspiratory Vital Capacity) 2 hours post inhalation
Time frame: Day 1 and 85
Number of patients having a COPD exacerbation
Time frame: 12 weeks
Number of patients being hospitalised due to a COPD exacerbation
Time frame: 12 weeks
Number of COPD exacerbations per patient
Time frame: 12 weeks
Number hospitalisations due to COPD exacerbations per patient
Time frame: 12 weeks
Duration of COPD exacerbations per patient
Time frame: 12 weeks
Duration of hospitalisations due to a COPD exacerbation
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
Related InfoLink provided by the sponsor.

Related trials for Pulmonary Disease, Chronic Obstructive

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim Study Coordinator study chair

Boehringer Ingelheim KG

177 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tiotropium bromide in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 177 sites in Germany.

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 8 inclusion and 18 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 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline in trough FEV1 (Forced expiratory volume in one second) (time frame: after 12 weeks). 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 NCT00274573.

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 21 Nov 2013.