drugset / Trial / NCT00394368

EFFICACY AND TOLERABILITY OF BECLOMETHASONE DIPROPIONATE 100 µg + FORMOTEROL 6 µg pMDI VIA HFA-134a vs. FLUTICASONE 125 µg + SALMETEROL 25 µg pMDI

NCT00394368 ↗

Phase 3 Completed 180 enrolled Chiesi Farmaceutici S.p.A.
RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of fluticasone/salmeterol pMDI in patients with moderate to severe asthma

Timeline

Start
2004-11
Primary completion
—
Completion
2005-09

Outcome

Met primary endpoint

paper The new combination of extrafine beclomethasone plus formoterol is not inferior to the marketed combination of fluticasone and salmeterol in terms of efficacy and tolerability PMID 17845589 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone propionate Other / unclassified 125 ug Inhaled
Subject Formoterol Other / unclassified 6 ug Inhaled
Subject beclomethasone dipropionate Other / unclassified 100 ug Inhaled
Subject salmeterol xinafoate Unknown 25 ug Inhaled

Indications