At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 141 enrolled
Drug / intervention
BI 1744 CL plus tiotropium bromide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomised, Double-blind, Cross-over Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of 2 Doses of Orally Inhaled BI 1744 CL, Each in Fixed Dose Combination (FDC) With 5 Microgram Tiotropium Bromide (Delivered by the Respimat® Inhaler) in Patients With COPD
In Brief
A Phase 2 clinical trial evaluating BI 1744 CL plus tiotropium bromide and Respimat® Inhaler for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 141 participants across 24 sites in 4 countries.
Detailed Summary
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesBelgium, Canada, Germany, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedJul 2008
Primary CompletionFeb 2009
TodayJul 2026
First PostedJul 22, 2008
Enrollment StartJul 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.9 years ago
Interventions
BI 1744 CL plus tiotropium bromidedrug
BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
Respimat® Inhalerdevice