Efficacy of aclidinium/formoterol fixed-dose combination versus salmeterol/fluticasone in COPD
Claus Vogelmeier (Marburg, Germany), Claus Vogelmeier, Pier Luigi Paggiaro, Jordi Dorca, Pawel Sliwinski, Marcel Mallet, Anne-Marie Kirsten, Beatriz Seoane, Rosa Maria Segarra, Anne Leselbaum, Esther Garcia Gil
Source: International Congress 2015 – New data on established treatments for asthma, COPD and bronchiectasis
Disease area: Airway diseases
Abstract Background Aclidinium bromide/formoterol fumarate fixed-dose combination (FDC) twice daily (BID) is licensed in Europe for COPD treatment.Aim To evaluate the efficacy of aclidinium/formoterol vs salmeterol/fluticasone propionate FDC (SAL/FLU) in patients (pts) with COPD.Methods A randomised, double-blind, Phase IIIb, 24-week study in pts with COPD Assessment Test (CAT) score ³ 10 compared aclidinium/formoterol 400/12 µg BID via Genuair® with SAL/FLU 50/500 µg BID via Accuhaler® (NCT01908140). Endpoints were peak FEV₁ (primary), Transition Dyspnoea Index (TDI; secondary), CAT, device preference and exacerbations. Non-inferiority of aclidinium/formoterol vs SAL/FLU was tested for peak FEV₁ and TDI. Superiority in peak FEV₁ was also analysed.Results 933 pts were randomised: mean age 63.4 years; 65.1% male; mean post-bronchodilator FEV₁ 1.48 L (53.2% predicted); mean CAT score 18.5. 788 pts (84.5%) completed the study.Aclidinium/formoterol achieved greater peak FEV₁ vs SAL/FLU from Day 1 to Week 24 (p<0.0001; Table). Improvements in TDI, CAT and exacerbations were similar in both groups (Table). More pts preferred Genuair (51.9%) than Accuhaler (18.5%, p<0.0001).Conclusion Superiority in peak FEV₁ and non-inferiority in TDI were demonstrated for aclidinium/formoterol FDC vs SAL/FLU in pts with stable COPD. Improvements in quality of life and exacerbations were similar in both groups. More pts preferred Genuair to Accuhaler.
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Claus Vogelmeier (Marburg, Germany), Claus Vogelmeier, Pier Luigi Paggiaro, Jordi Dorca, Pawel Sliwinski, Marcel Mallet, Anne-Marie Kirsten, Beatriz Seoane, Rosa Maria Segarra, Anne Leselbaum, Esther Garcia Gil. Efficacy of aclidinium/formoterol fixed-dose combination versus salmeterol/fluticasone in COPD. Eur Respir J 2015; 46: Suppl. 59, 2960
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