Beclomethasone/formoterol vs budesonide/formoterol combination therapy in asthma

¹ Research centre on Asthma and COPD, University of Ferrara, Ferrara, Italy
² Cardio-Thoracic Dept, Respiratory Pathophysiology, Pisa, Italy
³ Medical Dept, Chiesi Farmaceutici, Parma, Italy
⁴ Institute of Lung Pathophysiology, National Research Council, Palermo, Italy
⁵ Section of Respiratory Diseases, University of Modena, Modena, Italy

^* To whom correspondence should be addressed. E-mail: fabbri.leonardo{at}unimo.it.

	Abstract

The present study was designed to compare the fixed combination of beclomethasone and formoterol in HFA Modulite^® pMDI, with the combination of budesonide and formoterol given via the Turbuhaler^® dry powder inhaler.

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 mcg plus formoterol 12 mcg bid delivered via a pressurised metered dose inhaler or budesonide 400 mcg plus formoterol 12 mcg bid delivered via a dry powder inhaler.

The analysis of non-inferiority 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 rates of asthma exacerbations or frequency of adverse events.

The new fixed combination of beclomethasone and formoterol in HFA Modulite^® pMDI is equivalent to the marketed combination of budesonide and formoterol in terms of efficacy and tolerability profile.

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