In the first, double-blind study (n=1186, analysis population), patients were randomised to receive formoterol/beclometasone (total daily dose 24/400 microgram) or formoterol alone (total daily dose 24 microgram).
A significant improvement in lung function (as assessed by change in pre-dose morning FEV1 from baseline to week 12) was observed for formoterol/beclometasone compared with formoterol alone (adjusted mean difference 0.07 [95% CI 0.04-0.10], p<0.001).2
Formoterol/beclometasone also reduced the mean number of exacerbations per patient per year by 28% compared with formoterol alone (0.81 versus 1.11, adjusted rate ratio 0.72 [95% CI 0.62-0.84), p<0.001).2
In the second, three-arm parallel group study, 718 patients were randomised to receive treatment with formoterol/beclometasone metered dose inhaler (total daily dose 24/400 microgram), formoterol/budesonide dry powder inhaler (total daily dose 24/800 microgram) or formoterol dry powder inhaler (total daily dose 24 microgram).3
Formoterol/beclometasone was shown to be superior to formoterol alone (p=0.046) and non-inferior to formoterol/budesonide in terms of change in pre-dose morning FEV1 from baseline to 48 weeks.3
The mean rate of COPD exacerbations per patient per year was similar and did not differ significantly between the three treatment groups. All treatments were well tolerated.3
- Fostair Summary of Product Characteristics, March 2014.
- Agusti A et al. Poster presented at the European Respiratory Society Annual Congress. Barcelona, Spain, September 2013.
- Calverley PMA et al. Resp Med 2010; 104: 1858–68.
Further information: Chiesi Ltd