Efficacy of aclidinium/formoterol fixed-dose combination versus salmeterol/fluticasone in COPD
| Autor: | Esther Garcia Gil, Beatriz Seoane, Anne-Marie Kirsten, Anne Leselbaum, Jordi Dorca, Pierluigi Paggiaro, Pawel Sliwinski, Claus F. Vogelmeier, Rosa Segarra, Marcel Mallet |
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| Rok vydání: | 2015 |
| Předmět: |
Pulmonary and Respiratory Medicine
medicine.medical_specialty COPD Salmeterol fluticasone business.industry Fixed-dose combination respiratory system medicine.disease Gastroenterology Fluticasone propionate respiratory tract diseases Aclidinium bromide Internal medicine Anesthesia medicine Formoterol Fumarate Formoterol Salmeterol business medicine.drug |
| Zdroj: | 5.1 Airway Pharmacology and Treatment. |
| Popis: | 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 ≥10 compared aclidinium/formoterol 400/12 µg BID via Genuair® with SAL/FLU 50/500 µg BID via Accuhaler® ([NCT01908140][1]). 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 |
| Databáze: | OpenAIRE |
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