At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 459 enrolled
Drug / intervention
Fluticasone/Salmeterol Diskus +2 moredrug
Likely dose
Not stated in 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.
Long-acting Beta Agonist Step Down Study
In Brief
A Phase 4 clinical trial evaluating Fluticasone/Salmeterol Diskus and Fluticasone Diskus for Asthma. Completed, enrolled 459 participants across 19 sites.
Detailed Summary
This study is a 56-week, multi-center, blinded, randomized, double-masked parallel group comparative effectiveness study of approaches to stepping down therapy for patients with well-controlled asthma treated with combination ICS and LABA.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
CollaboratorsAmerican Lung Association, GlaxoSmithKline
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2011
Enrollment StartMar 2012
Primary CompletionSep 2015
Study CompletionOct 2015
TodayJul 2026
First PostedSep 21, 2011
Enrollment StartMar 1, 2012
Primary CompletionSep 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 14.8 years ago
Interventions
Fluticasone/Salmeterol Diskusdrug
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskusdrug
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone Diskusdrug
Fluticasone Diskus alone 250 ug twice daily without Salmeterol