At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 335 enrolled
Drug / intervention
indacaterol +2 moredrug
Likely dose
indacaterol 75 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 Multicenter, Randomized, Double-blind, Placebo-controlled, 12-week Treatment, Parallel-group Study to Assess the Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate (75 and 150 µg o.d.) in Patients With Persistent Asthma
In Brief
A Phase 2 clinical trial evaluating indacaterol, placebo, and 1 other intervention for Asthma. Completed, enrolled 335 participants across 96 sites in 8 countries.
Detailed Summary
To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBulgaria, Canada, Germany, Japan, Netherlands, Poland, Slovakia, South Korea
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartAug 2012
Primary CompletionJul 2013
TodayJul 2026
First PostedJun 1, 2012
Enrollment StartAug 1, 2012
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.1 years ago
Interventions
indacateroldrug
indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler
placebodrug
placebo delivered via Concept 1 inhaler
mometasone furoatedrug
via Twisthaler inhaler