Abstract
Background: Fluticasone (FLUT) and formoterol (FORM) are widely prescribed for asthmatics. A combination of FLUT/FORM in a single aerosol inhaler (flutiform®) has now been developed. This trial aimed to determine if FLUT/FORM is non-inferior to budesonide/formoterol (BUD/FORM; single inhaler) with regards to efficacy, and to assess safety, in adolescents and adults with moderate-to-severe persistent reversible asthma.
Methods: Eligible patients had an FEV1 of ≥50% to ≥80% for predicted normal values and a ≥15% reversibility in FEV1 following salbutamol (up to 400μg). 279 patients were randomised to FLUT/FORM 250/10μg b.i.d. (n=140) or BUD/FORM 400/12μg b.i.d. (n=139) in this 12 week, double-blind, 2-arm, parallel-group trial. The primary efficacy measure was change in morning pre-dose FEV1 from baseline to Week 12.
Results: 261 patients completed (FLUT/FORM; n=133; BUD/FORM; n=128). Both treatment groups showed improvements in morning pre-dose FEV1 from baseline to Week 12. FLUT/FORM was shown to be non-inferior to BUD/FORM because the lower limit of the 95% CI of the treatment difference (FLUT/FORM – BUD/FORM) was greater than the pre-defined threshold value of -0.2L (95% CI: -0.130, 0.043L). One patient on FLUT/FORM discontinued due to AEs (asthma exacerbation: not related) vs 3 patients on BUD/FORM (asthma exacerbation, acute sinusitis: not related; asthma exacerbation: possibly related).
Conclusions: Fluticasone/formoterol combination improved morning pre-dose FEV1 over 12 weeks of treatment; demonstrated comparable efficacy to BUD/FORM with regards to this key lung function measure of asthma control and had a similar safety profile.
- © 2011 ERS
