drugset / Trial / NCT00528723

Efficacy and Tolerability of Beclomethasone Plus Salbutamol in HFA pMDI Fixed Combination vs Beclomethasone Plus Salbutamol in CFC pMDI Fixed Combination in a 12-week Treatment Period of Adult Patients With Uncontrolled Asthma

NCT00528723

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

Summary

The purpose of this trial is to verify if the test treatment BDP 250 mcg/salbutamol 100 mcg HFA pMDI fixed combination is non-inferior to BDP 250 mcg/salbutamol 100 mcg pMDI fixed combination given with the conventional CFC propellant (Clenil® Compositum 250, Chiesi Farmaceutici) in terms of Pulmonary Function (morning PEF).

Timeline

Start
2007-11
Primary completion
2009-01
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Salbutamol Unknown 100 ug
Subject Salbutamol Unknown 400 ug
Subject beclomethasone dipropionate Other / unclassified 1000 ug

Indications