drugset / Trial / NCT02141854

Efficacy and Safety Study of FP MDPI Compared With FS MDPI in Adolescent and Adult Patients With Persistent Asthma

NCT02141854

Phase 3 Completed 882 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective of this study was to evaluate the efficacy of fluticasone propionate (Fp) multidose dry powder inhaler (MDPI) and fluticasone propionate/salmeterol xinafoate (FS) MDPI when administered over 12 weeks in patients 12 years of age and older with persistent asthma.

Timeline

Start
2014-06
Primary completion
2015-09
Completion
2015-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 100 ug Inhaled
Subject Fluticasone propionate Other / unclassified 200 ug Inhaled
Background salmeterol xinafoate Unknown 12.5 ug Inhaled
Background Salbutamol Unknown Inhaled
Background salmeterol xinafoate Unknown Inhaled

Indications