MedDataX Logo

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

NCT ID: NCT00274573

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1639 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tiotropium bromide

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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.
2. Male or female patients 40 years of age or older.
3. 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)
4. 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.
5. Patients must be able to inhale medication from the HandiHaler.
6. 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.

Exclusion Criteria

1. 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.
2. Patients with a recent history (i.e., one year or less) of myocardial infarction.
3. Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years.
4. 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.
5. Patients with known active tuberculosis.
6. Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
7. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
8. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1.
9. Patients with any respiratory infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period.
10. 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).
11. Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
12. Patients with known symptomatic prostate hypertrophy or bladder neck obstruction.
13. Patients with known narrow-angle glaucoma.
14. 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.
15. 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).
16. Patients with a history of asthma, allergic rhinitis or atopy.
17. Patients with a history of and/or active significant alcohol or drug abuse.
18. 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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim KG

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boehringer Ingelheim Investigational Site

Aachen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Ahrensburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Altenburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Amberg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Aschaffenburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Aue, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Auerbach, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Augsburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Backnang, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Bad Kissingen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Bad Krozingen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Bad Lippspringe, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Bad Nauheim, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Bad Neustadt an der Saale, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Bad Soden, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Baunatal, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Beckum, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Bensheim, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

MEDARS GmbH

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Bernau, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Bielefeld, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Bochum, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Bonn, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Brake, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Brandenburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Braunschweig, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Bruchsal, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Buchholz, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Celle, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Chemnitz, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Cloppenburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Coburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Cologne, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Dachau, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Darmstadt, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Deggendorf, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Delmenhorst, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Detmold, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Dillingen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Dinslaken, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Dortmund, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Dresden, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Duisburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Dülmen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Düren, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Düsseldorf, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Eggenfelden, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Eisenach, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Eisenhüttenstadt, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Emden, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Erfurt, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Erlangen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Essen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Euskirchen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Fellbach, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Fluda, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Frankenthal, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Frankfurt (Oder), , Germany

Site Status

Boehringer Ingelheim Investigational Site

Frankfurt am Main, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Freising, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Fulda, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Fürstenfeldbruck, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Fürstenwalde, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Fürth, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Garmisch-Partenkirchen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Gelsenkirchen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Germering, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Goch, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Göppingen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Greiz, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Groß Gaglow, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Großenhain, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Gütersloh, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hagen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hamm, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hartha, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Heidelberg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Heidenheim, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Heilbronn, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hemmingen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hildburghausen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hildesheim, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Homburg/Saar, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hoyerswerda, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Ingolstadt, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Kamen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Karlsruhe, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Kaufbeuren, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Kempten, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Kiel, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Koblenz, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Köthen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Krefeld, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Landshut, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Langenhagen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Leipzig, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Leonberg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Loerrach, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Ludwigsburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Lübeck, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Lüdenscheid, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Lüneburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Magdeburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

Johannes-Gutenberg-Universität Mainz

Mainz, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Mannheim, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Marburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Markkleeberg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Minden, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Mittweida, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Moers, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Mönchengladbach, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Mühlhausen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Münster, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Neu-Isenburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Neu-Ulm, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Neubrandenburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Neuss, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Neuwied, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Niesky, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Nordhausen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Nortorf, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Oschatz, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Oschersleben, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Papenburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Potsdam, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Rathenow, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Recklinghausen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Regensburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Rehau, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Remscheid, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Reutlingen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Rhaunen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Rostock, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Rüdersdorf, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Rüsselsheim am Main, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Saarbrücken, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Saarlouis, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Saint Ingbert, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Schrobenhausen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Schwabach, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Schwäbisch Gmünd, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Schweinfurt, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Schwetzingen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Siegen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Simmern, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Sindelfingen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Singen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Solingen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Sonneberg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Stade, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Steinhagen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Stolberg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Stuttgart, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Teuchern, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Ulm, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Uttenreuth, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Vechta, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Velbert, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Verden an der Aller, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Vöhringen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Waiblingen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Waren, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Welzheim, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Weyhe, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Wiesbaden, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Wiesloch, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Witten, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Wolfsburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Wuppertal, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Zerbst, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Zwickau, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

205.257

Identifier Type: -

Identifier Source: org_study_id