At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 344 enrolled
Drug / intervention
Tiotropium plus Salmeterol +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.
Effect of Inhalation of a Free Combination of Tiotropium Once Daily 18 Mcg and Salmeterol Twice Daily 50 Mcg Versus a Fixed Combination of Fluticasone and Salmeterol Twice Daily (500/50 Mcg) on Static Lung Volumes and Exercise Tolerance in COPD Patients (a Randomised, Double-blind, Double Dummy, 16 (2 x 8) Weeks, Crossover Study).
In Brief
A Phase 4 clinical trial evaluating Tiotropium plus Salmeterol and Fluticasone/Salmeterol for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 344 participants across 42 sites in 7 countries.
Detailed Summary
The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD. The secondary objective includes assessment of safety.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesAustria, Canada, France, Germany, Italy, Russia, Sweden
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedSep 2007
Primary CompletionJan 2009
TodayJul 2026
First PostedSep 18, 2007
Enrollment StartSep 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.8 years ago
Interventions
Tiotropium plus Salmeteroldrug
Fluticasone/Salmeteroldrug