CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11,751 enrolled
Drug / intervention
ADVAIR 100/50mcg +5 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/NCT01475721
NCT01475721Phase 4Completed
CompareCT.gov

SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects With Asthma

GlaxoSmithKline·interventional·Posted Nov 21, 2011·Updated Aug 6, 2018

In Brief

A Phase 4 clinical trial evaluating ADVAIR 100/50mcg, ADVAIR 250/50mcg, and 4 other interventions for Asthma. Completed, enrolled 11,751 participants across 808 sites in 33 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 adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone. ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.

Study Details

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

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 21, 2011
Enrollment StartNov 18, 2011
Primary CompletionJun 23, 2015
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.6 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

ADVAIR 500/50mcgdrug

fluticasone propionate/salmeterol combination (500/50mcg) 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

FLOVENT 500mcgdrug

fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months