EUCTR2008-000562-23-DEActive, not recruitingNot Applicable
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
Boehringer Ingelheim Pharma GmbH & Co.KG0 sites96 target enrollmentStarted: May 6, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 96
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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