At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 351 enrolled
Drug / intervention
fluticasone propionate +1 moredrug
Likely dose
fluticasone propionate 100mcgfrom 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 Randomized, Double-blind, Parallel Group Study Evaluating the Safety of Fluticasone Propionate/Salmeterol 100/50mcg HFA (2 Inhalations of 50/25mcg) Twice Daily Compared With Fluticasone Propionate 100mcg HFA (2 Inhalations of 50mcg) Twice Daily in Subjects 4-11 Years of Age With Persistent Asthma
In Brief
A Phase 3 clinical trial evaluating fluticasone propionate and fluticasone propionate/salmeterol for Asthma. Completed, enrolled 351 participants across 55 sites in 13 countries.
Detailed Summary
This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesAustralia, Canada, Chile, Costa Rica, Germany, Latvia, Lithuania, Mexico, Peru, Poland, Russia, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2007
First PostedMar 2007
Primary CompletionJan 2008
TodayJul 2026
First PostedMar 1, 2007
Enrollment StartFeb 1, 2007
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 19.3 years ago
Interventions
fluticasone propionatedrug
fluticasone propionate 100mcg HFA
fluticasone propionate/salmeteroldrug
fluticasone propionate/salmeterol 100/50mcg HFA