TY - JOUR T1 - Efficacy and safety of single-inhaler triple therapy of glycopyrronium, formoterol, and fluticasone in patients with chronic obstructive pulmonary disease: a double-blind, randomised controlled trial JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00255-2021 SP - 00255-2021 AU - Sundeep Salvi AU - Akash Balki AU - Srikanth Krishnamurthy AU - Sagar Panchal AU - Saiprasad Patil AU - Rahul Kodgule AU - Hitesh Khandagale AU - Amol Pendse AU - Wen Wu AU - Shabbir Rangwala AU - Monika Tandon AU - Hanmant Barkate Y1 - 2021/01/01 UR - http://openres.ersjournals.com/content/early/2021/05/13/23120541.00255-2021.abstract N2 - Background Investigating the safety and efficacy of single-inhaler triple therapy with glycopyrronium (GB) 12.5 μg/formoterol fumarate (FF) 12 μg/fluticasone propionate (FP) 250 μg, compared to GB 50 μg co-administered with a fixed dose of FF 12 μg/FP 250 μg in subjects with COPD.Methods A phase 3, randomised, double-blind, active-control, parallel-group, noninferiority study conducted at 20 sites across India. COPD patients aged ≥40 to ≤75 years, with FEV1/FVC <0.70, using mono/dual therapy with ICS, LAMA, or LABA for ≥1 month, were included. Subjects were randomised 1:1 to GB/FF/FP or GB+FF/FP for 12 weeks. Primary efficacy endpoint was the change from baseline in trough FEV1 at the end of 12 weeks. The study is registered with the Clinical Trials Registry of India (CTRI Reg No: CTRI/2019/01/017156).Results Between March 23, 2019 and February 14, 2020, 396 subjects were enrolled, 198 patients each in the fixed-triple (GB/FF/FP) and open-triple (GB+FF/FP) groups. The difference in LSM changes in predose FEV1 from baseline at 12 weeks was noninferior between the groups (p<0.05). The LSM change from baseline in postdose FEV1 was comparable (p=0.38). Superiority test showed comparable efficacy (p =0.12) for the difference in mean change from baseline in trough FEV1 between the groups. Adverse events (mild or moderate) were recorded in 25.3% and 24.9% of subjects in the GB/FF/FP and GB+FF/FP groups.Conclusions Fixed triple therapy with GB/FF/FP provides comparable bronchodilation and lung function improvement like open triple therapy. It is safe and well-tolerated in symptomatic COPD patients with a history of exacerbations.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of Interest: Dr. Sundeep Salvi has nothing to disclose.Conflict of Interest: Dr. Akash Balki has nothing to disclose.Conflict of Interest: Dr. Srikanth Krishnamurthy has nothing to disclose.Conflict of Interest: Dr. Sagar Panchal is employee of Glenmark pharmaceuticals.Conflict of Interest: Dr. Saiprasad Patil is employee of Glenmark pharmaceuticals.Conflict of Interest: Dr. Rahul Kodgule is employee of Glenmark pharmaceuticals.Conflict of Interest: Mr. Hitesh Khandagale is employee of Glenmark pharmaceuticals.Conflict of Interest: Mr. Amol Pendse is employee of Glenmark pharmaceuticals.Conflict of Interest: Mr. Wen Wu is employee of Glenmark pharmaceuticals.Conflict of Interest: Mr. Shabbir Rangwala is employee of Glenmark pharmaceuticals.Conflict of Interest: Dr. Monika Tandon is employee of Glenmark pharmaceuticals.Conflict of Interest: Dr. Hanmant Barkate is employee of Glenmark pharmaceuticals. ER -