HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) An erratum has been published A correction has been published Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via ISI Web of Science (4) Citing Articles via Google Scholar Google Scholar Articles by Papi, A. Search for Related Content PubMed PubMed Citation Articles by Papi, A.

Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma

A. Papi¹, P. L. Paggiaro², G. Nicolini³, A. M. Vignola, ⁴, L. M. Fabbri⁵ on behalf of the Inhaled Combination Asthma Treatment versus SYmbicort (ICAT SY) study group⁶

¹ Research centre on Asthma and COPD, University of Ferrara, Ferrara, ² Cardio-Thoracic Dept, Respiratory Pathophysiology, University of Pisa, Pisa, ³ Medical Dept, Chiesi Farmaceutici, Parma, ⁴ Institute of Lung Pathophysiology, National Research Council, Palermo, and, ⁵ Section of Respiratory Diseases, University of Modena, Modena, Italy. ⁶ Members have been listed in the Acknowledgements section.

CORRESPONDENCE: L. M. Fabbri, Dept of Respiratory Diseases, University of Modena & Reggio Emilia, Via del Pozzo 71, I-41100 Modena, Italy. Fax: 39 0594224231. E-mail: fabbri.leonardo{at}unimo.it

Keywords: Asthma, beclomethasone, budesonide, combined therapy, extrafine, formoterol

Received: July 21, 2006
Accepted November 3, 2006

The present study was designed to compare the fixed combination of beclomethasone and formoterol in a hydrofluoroalkane Modulite® (Chiesi Farmaceutici, Parma, Italy) pressurised metered-dose inhaler (pMDI), with a combination of budesonide and formoterol administered via a Turbuhaler® (AstraZeneca, Lund, Sweden) dry powder inhaler (DPI).

This was a phase III, multinational, multicentre, double-blind, double-dummy, randomised, two-arm parallel groups, controlled study design. After a 2-week run-in period, 219 patients with moderate-to-severe asthma were randomised to a 12-week treatment with beclomethasone 200 µg plus formoterol 12 µg b.i.d. delivered via a pMDI or budesonide 400 µg plus formoterol 12 µg b.i.d. delivered via a DPI.

The analysis of noninferiority on primary outcome, morning peak expiratory flow in the last 2 weeks of treatment, showed no difference between groups. A statistically significant improvement from baseline in lung function, symptoms and rescue medication use was observed in both groups at all time-points. No differences were observed between treatments in either rate of asthma exacerbations or frequency of adverse events.

The new fixed combination of beclomethasone and formoterol in hydrofluoroalkane Modulite® pressurised metered-dose inhaler is equivalent to the marketed combination of budesonide and formoterol in terms of efficacy and tolerability profile.