Efficacy and Tolerability of Beclomethasone Dipropionate 100 µg + Formoterol 6 µg pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler®. (Symbicort®)

Phase 3 Completed 219 enrolled Chiesi Farmaceutici S.p.A.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of budesonide/formoterol dry powder via Turbuhaler.

Timeline

Start: 2004-09
Primary completion: 2005-08
Completion: 2005-10

Publications

Results Papi A, Paggiaro PL, Nicolini G, Vignola AM, Fabbri LM; Inhaled Combination Asthma Treatment versus SYmbicort (ICAT SY) Study Group. Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma. Eur Respir J. 2007 Apr;29(4):682-9. doi: 10.1183/09031936.00095906. Epub 2006 Nov 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Budesonide	Small molecule	200 ug	Inhaled
Subject	beclomethasone dipropionate	Other / unclassified	100 ug	Inhaled
Comparator	Formoterol	Other / unclassified	6 ug	Inhaled

Efficacy and Tolerability of Beclomethasone Dipropionate 100 µg + Formoterol 6 µg pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler®. (Symbicort®)

Summary

Timeline

Publications

Drugs

Indications