drugset / Trial / NCT00734318

Study of FlutiForm® Versus Fluticasone Plus Formoterol in Adult Subjects With Severe Asthma

NCT00734318 ↗

Phase 3 Completed 1667 enrolled Mundipharma Research Limited
RandomizedParallel-groupDouble-blindTreatment

Summary

The study compares the efficacy and safety of FlutiForm® vs Flixotide® plus Foradil® in the treatment of severe persisent asthma in adult subjects.

Timeline

Start
2008-09
Primary completion
2009-06
Completion
2009-10

Outcome

Met primary endpoint

paper primary outcome measure: there were similar increases in mean pre-morning dose forced expiratory volume in the first second (FEV(1)) PMID 21196104 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone propionate Other / unclassified 250 ug Inhaled
Subject Flutiform Unknown — Inhaled
Comparator Formoterol Other / unclassified 24 ug Inhaled

Indications