دورية أكاديمية
Efficacy and Safety of Aclidinium Bromide Compared with Placebo and Tiotropium in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease: Results from a 6-week, Randomized, Controlled Phase Iiib Study
| العنوان: | Efficacy and Safety of Aclidinium Bromide Compared with Placebo and Tiotropium in Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease: Results from a 6-week, Randomized, Controlled Phase Iiib Study |
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| المؤلفون: | Jutta Beier, Anne-Marie Kirsten, Robert Mróz, Rosa Segarra, Ferran Chuecos, Cynthia Caracta, Esther Garcia Gil |
| المصدر: | COPD, Vol 10, Iss 4, Pp 511-522 (2013) |
| بيانات النشر: | Taylor & Francis Group, 2013. |
| سنة النشر: | 2013 |
| المجموعة: | LCC:Diseases of the respiratory system |
| مصطلحات موضوعية: | 24-hour, bronchodilation, long-acting muscarinic antagonist, nighttime, symptoms, Diseases of the respiratory system, RC705-779 |
| الوصف: | AbstractBackground: This randomized, double-blind, Phase IIIb study evaluated the 24-hour bronchodilatory efficacy of aclidinium bromide versus placebo and tiotropium in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). Methods: Patients received aclidinium 400 μg twice daily (morning and evening), tiotropium 18 μg once daily (morning), or placebo for 6 weeks. The primary endpoint was change from baseline in forced expiratory volume in 1 second area under the curve for the 24-hour period post-morning dose (FEV1 AUC0–24) at week 6. Secondary and additional endpoints included FEV1 AUC12–24, COPD symptoms (EXAcerbations of chronic pulmonary disease Tool-Respiratory Symptoms [E-RS] total score and additional symptoms questionnaire), and safety. Results: Overall, 414 patients were randomized and treated (FEV1 1.63 L [55.8% predicted]). Compared with placebo, FEV1 AUC0–24 and FEV1 AUC12–24 were significantly increased from baseline with aclidinium (∆ = 150 mL and 160 mL, respectively; p < 0.0001) and tiotropium (∆ = 140 mL and 123 mL, respectively; p < 0.0001) at week 6. Significant improvements in E-RS total scores over 6 weeks were numerically greater with aclidinium (p < 0.0001) than tiotropium (p < 0.05) versus placebo. Only aclidinium significantly reduced the severity of early-morning cough, wheeze, shortness of breath, and phlegm, and of nighttime symptoms versus placebo (p < 0.05). Adverse-event (AE) incidence (28%) was similar between treatments. Few anticholinergic AEs ( |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 15412555 1541-2563 1541-2555 |
| Relation: | https://doaj.org/toc/1541-2555; https://doaj.org/toc/1541-2563 |
| DOI: | 10.3109/15412555.2013.814626 |
| URL الوصول: | https://doaj.org/article/dc395413bf4942b1a3f2071d24e9137b |
| رقم الأكسشن: | edsdoj.395413bf4942b1a3f2071d24e9137b |
| قاعدة البيانات: | Directory of Open Access Journals |
PDF full text from Publisher | تدمد: | 15412555 15412563 |
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| DOI: | 10.3109/15412555.2013.814626 |