At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 96 enrolled
Drug / intervention
Indacaterol +3 moredrug
Likely dose
Indacaterol 300 µgfrom 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.
A Phase III Randomized, Double Blind, Double Dummy, Placebo Controlled, Multicenter, 4 Treatments, 3 Period Incomplete Block Crossover Study to Assess the Efficacy and Safety of Indacaterol 300 µg o.d. Dosed in the Evening in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Salmeterol 50 µg b.i.d. as Active Control
In Brief
A Phase 3 clinical trial evaluating Indacaterol, Salmeterol, and 2 other interventions for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 96 participants across 7 sites in 3 countries.
Detailed Summary
This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second \[FEV1\]) over the full 24-h time period
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedFeb 2008
Primary CompletionJul 2008
Study CompletionAug 2008
TodayJul 2026
First PostedFeb 14, 2008
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2008
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.4 years ago
Interventions
Indacateroldrug
300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI)
Salmeteroldrug
50 µg twice daily delivered via dry powder inhaler (DPI)
Placebo to Indacateroldrug
Placebo matching indacaterol was delivered via SDDPI.
Placebo to Salmeteroldrug
Placebo matching salmeterol was delivered via DPI