drugset / Trial / NCT00830505

Fluticasone/Salmeterol (FP/SM) Versus Double the Dose Fluticasone (FP) in Patients With Mild to Moderate Asthma

NCT00830505 ↗

Phase 4 Completed 38 enrolled University of Dundee
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to compare the effects of Fluticasone/ salmeterol combination and double the dose of fluticasone on airway hyper-responsiveness to methacholine in a randomised, double blind, double dummy, cross-over trial.

Timeline

Start
2009-04
Primary completion
2010-05
Completion
2010-05

Outcome

Met primary endpoint

paper The patients who smoked gained a benefit from FP/SM but not fluticasone, amounting to a PC(20) difference of 1.6 doubling dilutions (95% CI, 1.0-2.2), P < .01. PMID 21636667 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone Other / unclassified 125 ug Inhaled
Comparator Fluticasone Other / unclassified 250 ug Inhaled
Subject Salmeterol Other / unclassified 25 ug Inhaled

Indications