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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274573
• Other study ID #: 205.257
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2006
• Last updated: November 20, 2013
• Start date: March 2002

Study information

• Verified date: November 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1639
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium bromide

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in trough FEV1 (Forced expiratory volume in one second)		after 12 weeks	No
Primary	Change from baseline in FEV1 2 hours post inhalation		after 12 weeks	No
Secondary	Change from baseline in FEV1 2 hours post inhalation		Day 1	No
Secondary	Change from baseline in FVC (Forced Vital Capacity) 2 hours post inhalation		Day 1 and 85	No
Secondary	Change from baseline in IVC (Inspiratory Vital Capacity) 2 hours post inhalation		Day 1 and 85	No
Secondary	Number of patients having a COPD exacerbation		12 weeks	No
Secondary	Number of patients being hospitalised due to a COPD exacerbation		12 weeks	No
Secondary	Number of COPD exacerbations per patient		12 weeks	No
Secondary	Number hospitalisations due to COPD exacerbations per patient		12 weeks	No
Secondary	Duration of COPD exacerbations per patient		12 weeks	No
Secondary	Duration of hospitalisations due to a COPD exacerbation		12 weeks	No

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