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8390685 
Journal Article 
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 
Kerwin, E; Ferguson, GT; Sanjar, S; Goodin, T; Yadao, A; Fogel, R; Maitra, S; Sen, B; Ayers, T; Banerji, D 
2017 
1 
Lung
ISSN: 0341-2040
EISSN: 1432-1750 
Springer New York LLC 
195 
6 
739-747 
English 
28993871 
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 (FEV1 AUC0–24). Rescue medication use, symptom control, and safety were assessed throughout. Results: Both treatments delivered substantial bronchodilation over 12 weeks, with improvements in FEV1 AUC0–24h at week 12 of 232 and 185 mL for IND/GLY, and 244 and 203 mL with UMEC/VI in Studies A2349 and A2350, respectively. The primary efficacy objective of non-inferiority of IND/GLY relative to UMEC/VI was not met as the lower bound of the confidence interval for the LS treatment comparison was below the pre-specified non-inferiority margin of −20 mL in both studies: −26.9 and −34.2 mL, respectively (LS mean between-treatment differences: −11.5 and −18.2 mL). Both drugs were well tolerated, with AE profiles consistent with their respective prescribing information. 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). © 2017, Springer Science+Business Media, LLC. 
COPD; Indacaterol/glycopyrrolate; Long-acting muscarinic antagonist; Long-acting β2-agonists; Non-inferiority trial; Umeclidinium/vilanterol