CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 621 enrolled
Drug / intervention
Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID +1 moredrug
Likely dose
Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BIDfrom 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/NCT00452699
NCT00452699Phase 4Completed
CompareCT.gov

A 52-week, Randomized, Double-Blind, Parallel-Group Study of Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 mcg BID and Fluticasone Propionate (FP) DISKUS 250 mcg BID in Treatment of Subjects With Asthma

GlaxoSmithKline·interventional·Posted Mar 27, 2007·Updated Dec 8, 2016

In Brief

A Phase 4 clinical trial evaluating Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID and Fluticasone propionate 250 mcg BID for Asthma. Completed, enrolled 621 participants across 74 sites in 5 countries.

Detailed Summary

This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Brazil, Canada, Philippines, United States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 27, 2007
Enrollment StartMay 1, 2007
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19.3 years ago

Interventions

Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BIDdrug

Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID

Fluticasone propionate 250 mcg BIDdrug

Fluticasone propionate 250 mcg BID