At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 79 enrolled
Drug / intervention
Indacaterol acetate 75 μg +1 moredrug
Likely dose
Indacaterol acetate 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, Active-controlled, 2 Week Treatment, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol Acetate Delivered Via the Concept1 Inhalation Device in Children Greater or Equal to 6 and Less Than 12 Years of Age With Asthma
In Brief
A Phase 2 clinical trial evaluating Indacaterol acetate 75 μg and Indacaterol acetate 150 μg for Asthma. Completed, enrolled 79 participants across 29 sites in 11 countries.
Detailed Summary
This study is designed to explore lung function effects of two doses of indacaterol acetate, 75 μg and 150 μg, in pediatric asthma patients 6-11 years old, and to compare the systemic exposure to indacaterol in plasma with historical data in adults, to identify an appropriate dose to Phase III evaluation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBelgium, Colombia, Croatia, Germany, Guatemala, Hungary, Philippines, Russia, Slovakia, South Africa, Turkey (Türkiye)
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 2016
Enrollment StartApr 2017
Primary CompletionJun 2019
Study CompletionJul 2019
TodayJul 2026
First PostedSep 8, 2016
Enrollment StartApr 18, 2017
Primary CompletionJun 19, 2019
Study CompletionJul 17, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.8 years ago
Interventions
Indacaterol acetate 75 μgdrug
Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler
Indacaterol acetate 150 μgdrug
Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler