Randomised, Double-Blind, Cross-over Study to Assess the Efficacyand Safety of 4 Weeks of Once Daily Treatment of 2 Doses of OrallyInhaled BI 1744 CL, each in fixed dose combination (FDC) with 5µgTiotropium Bromide (Delivered by the Respimat® Inhaler) in Patientswith COPD - Efficacy and Safety of 4 Weeks QD orally inhaled FDC BI 1744/tiotropium via RESPIMAT in COPD

• Conditions: Chronic obstructive pulmonary disease (COPD); MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD

• Registration Number: EUCTR2008-000562-23-DE
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co.KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-06
• Last Update Posted: 28 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Signed informed consent, diagnosis of COPD, post-bronchodilator FEV1 of more or equal 30% of predicted normal and less than 80% of predicted normal, 40 years of age or older, current or ex-smokers with a smoking history of more than 10 pack-years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Significant disease other than COPD, abnormal baseline laboratory, history of asthma or total blood eosinophil count of equal or more than 600 per mm3, history of myocardial infarction/life-threatening pulmonary obstruction/cystic fibrosis/bronchiectasis/alcohol or drug abuse, treatment with medications which prolong the QT/QTc interval, treatment with oral ß-adrenergics/ß-blockers/oral corticosteroids at unstable doses or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day, use of daytime oxygen for more than one hour per day, currently undergoing rehabilitation (or within prior 6 weeks), other investigational drug, known hypersensitivity to ß-adrenergics or anticholinergics or other components of the drug product

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Trough FEV1 response [L] after four weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from study baseline in trough FEV1. Study baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (-1 hour and -10 minutes) prior to administration of the first dose of study medication.;Main Objective: The primary objective is to determine the optimum dose of BI 1744 CL administered as a fixed combination with 5 mcg tiotropium bromide solution for inhalation delivered by the Respimat inhaler, once daily for four weeks in patients with COPD. <br>;Secondary Objective: Secondary endpoints include trough FEV1 response after 2 weeks of treatment, FVC, PEF, number of occasions of rescue therapy use, and Physician's and Patient's Global Evaluation/Rating.