CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 6,250 enrolled
Drug / intervention
ADVAIR 100/50mcg +3 moredrug
Likely dose
ADVAIR 100/50mcgfrom 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.

Search/NCT01462344
NCT01462344Phase 4Completed
CompareCT.gov

A 6-month Safety and Benefit Study of Inhaled Fluticasone Propionate/ Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of 6,200 Pediatric Subjects 4-11 Years Old With Persistent Asthma

GlaxoSmithKline·interventional·Posted Oct 31, 2011·Updated Aug 6, 2018

In Brief

A Phase 4 clinical trial evaluating ADVAIR 100/50mcg, ADVAIR 250/50mcg, and 2 other interventions for Asthma. Completed, enrolled 6,250 participants across 530 sites in 32 countries.

Detailed Summary

The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Germany, Hungary, Italy, Latvia, Lithuania, Malaysia, Mexico, Peru, Philippines, Poland, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
CollaboratorsParexel

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 31, 2011
Enrollment StartNov 17, 2011
Primary CompletionNov 1, 2015
Study CompletionNov 3, 2015
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 14.7 years ago

Interventions

ADVAIR 100/50mcgdrug

fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months

ADVAIR 250/50mcgdrug

fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months

FLOVENT 100mcgdrug

fluticasone propionate (100) twice daily (AM and PM) for 6 months

FLOVENT 250mcgdrug

fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months