Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies.
Autor: | Kerwin E; Clinical Research Institute, Medford, OR, USA., Ferguson GT; Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA., Sanjar S; Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, USA., Goodin T; Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA, USA., Yadao A; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Fogel R; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Maitra S; Novartis Healthcare Pvt. Ltd., Hyderabad, India., Sen B; Novartis Healthcare Pvt. Ltd., Hyderabad, India., Ayers T; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA., Banerji D; Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. donald.banerji@novartis.com. |
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Jazyk: | angličtina |
Zdroj: | Lung [Lung] 2017 Dec; Vol. 195 (6), pp. 739-747. Date of Electronic Publication: 2017 Oct 09. |
DOI: | 10.1007/s00408-017-0055-9 |
Abstrakt: | Purpose: To compare the efficacy and safety of two long-acting dual bronchodilator combinations: indacaterol/glycopyrrolate (IND/GLY) versus umeclidinium/vilanterol (UMEC/VI). Methods: Studies A2349 and A2350 were replicate, randomized, double-blind, double-dummy, active-controlled, cross-over studies in patients with moderate-to-severe COPD. Patients were randomized to sequential 12-week treatments of twice-daily IND/GLY 27.5/15.6 μg and once-daily UMEC/VI 62.5/25 μg, each separated by a 3-week washout. The primary objective was to demonstrate non-inferiority of IND/GLY compared with UMEC/VI in terms of the 24-h forced expiratory volume in 1 s profile at week 12 (FEV Results: Both treatments delivered substantial bronchodilation over 12 weeks, with improvements in FEV Conclusions: IND/GLY and UMEC/VI provided clinically meaningful and comparable bronchodilation. Non-inferiority of IND/GLY to UMEC/VI could not be declared although between-treatment differences were not clinically relevant. The data support the use of IND/GLY as an efficacious and well tolerated treatment option in patients with COPD. (ClinicalTrials.gov NCT02487446 and NCT02487498). |
Databáze: | MEDLINE |
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