Abstract
Background: Phase 3 studies involving a new asthma therapy combining fluticasone (FLUT) and formoterol (FORM) in a single aerosol inhaler (FLUT/FORM; flutiform®) either used a spacer or did not. This is the first comparison of the efficacy and tolerability of treatment with or without the use of a spacer device.
Methods: Adults and adolescents with mild, moderate or moderate-severe asthma were treated with FLUT/FORM 100/10μg or 250/10μg b.i.d. delivered either with (N=195) or without (N=532) a spacer in 6 randomised, double-blind and open-label, parallel group studies. The endpoint was non-inferiority between spacer and non-spacer groups (concluded if the lower bound of the 95% CI was ≥-0.2L) in terms of changes in morning pre-dose FEV1 and morning pre-dose to 2h post-dose FEV1 over 12 weeks. The incidence of adverse events (AEs) was analysed over 8 weeks.
Results: FLUT/FORM was consistently as effective when delivered with or without a spacer at all dose strengths and asthma severities. From baseline to end of study, the LS mean treatment difference in morning pre-dose FEV1 was 0.067L greater without spacer (95% CI: -0.149, 0.015) and in morning pre-dose to 2h post-dose FEV1 was 0.015L greater with spacer (95% CI: -0.051, 0.081). AEs were reported with similar frequency both with and without a spacer (nasopharyngitis: 14 (2.1%) vs 34 (3.2%); asthma: 12 (1.8%) vs 17 (1.6%) patients; cough: 4 (0.6%) vs 10 (0.9%); dysphonia: 5 (0.7%) vs 7 (0.7%)).
Conclusions: Pooled analysis showed that fluticasone/formoterol may be given with or without a spacer device with both approaches providing similar efficacy and tolerability.
- © 2011 ERS
