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 microg plus formoterol 12 microg b.i.d. delivered via a pMDI or budesonide 400 microg plus formoterol 12 microg 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.

Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma / A., Papi; Paggiaro, P. L.; G., Nicolini; Vignola, A. M.; Fabbri, Leonardo. - In: EUROPEAN RESPIRATORY JOURNAL. - ISSN 0903-1936. - STAMPA. - 29:4(2007), pp. 682-689. [10.1183/09031936.00095906]

Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma.

FABBRI, Leonardo
2007

Abstract

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 microg plus formoterol 12 microg b.i.d. delivered via a pMDI or budesonide 400 microg plus formoterol 12 microg 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.
2007
29
4
682
689
Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma / A., Papi; Paggiaro, P. L.; G., Nicolini; Vignola, A. M.; Fabbri, Leonardo. - In: EUROPEAN RESPIRATORY JOURNAL. - ISSN 0903-1936. - STAMPA. - 29:4(2007), pp. 682-689. [10.1183/09031936.00095906]
A., Papi; Paggiaro, P. L.; G., Nicolini; Vignola, A. M.; Fabbri, Leonardo
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/584174
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