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Background: Inhaler errors among patients with chronic obstructive pulmonary disease (COPD) can reduce treatment efficacy., Methods: This randomized, open-label, crossover study evaluated correct use of ELLIPTA versus DISKUS plus HandiHaler. Participants with COPD attended at least 3 study visits (Day 1 [Visit 1], Day 28 [Visit 2], and Day 56 [Visit 3]). Inhalers contained placebo; usual maintenance medication was continued. Participants were randomized to an inhaler sequence (ELLIPTA then DISKUS plus HandiHaler, or the reverse) and preference questionnaire at Visit 1. Participants read the instructions for use in the approved prescribing information for their inhaler(s) and correct use was assessed at Visit 1 (verbal guidance provided if required). Correct use was reassessed at Visit 2, and with the next inhaler(s) at Visit 3. Primary endpoint was the proportion of participants demonstrating correct use (0 errors) with the assigned inhaler(s) after 28 days., Results: A greater proportion of study participants (n = 217) correctly used ELLIPTA (96%) versus DISKUS plus HandiHaler (87%) after 28 days. The odds of demonstrating correct use with ELLIPTA were 6.88 times that of DISKUS plus HandiHaler ( p < 0.001). Overall, > 99% of participants made 0 critical errors (errors leading to no or significantly reduced medication inhaled) with ELLIPTA versus 89% with DISKUS plus HandiHaler after 28 days. ELLIPTA was the patient-preferred option versus DISKUS plus HandiHaler or no preference ( p < 0.001)., Conclusions: Delivery of COPD maintenance therapy via ELLIPTA demonstrates higher correct use rates and lower critical error rates compared with DISKUS plus HandiHaler., Competing Interests: EMK has participated in consulting, advisory boards, speaker panels, or received travel reimbursement from Amphastar, AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline plc., Mylan, Novartis, Oriel, Pearl, Sunovion, Teva, and Theravance. He has conducted multicenter clinical research trials for approximately 40 pharmaceutical companies. SS has been a principal investigator for 20 years and has conducted clinical research trials for a large number of pharmaceutical companies. He has also participated as a consultant and on advisory boards and speaker panels for pharmaceutical companies including AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline plc., Mylan, Menlo, Novartis, Pearl, Sunovion, Teva, and Theravance. MZ, VM, RJ, KC, and RS are employees of, and own shares in, GlaxoSmithKline plc. Editorial support (in the form of writing assistance, collating author comments, assembling tables and/or figures, grammatical editing, fact checking, and referencing) was provided by Matthew Hallam, MSc(Res) and Joanna Wilson, PhD, of Gardine—Caldwell Communications (Macclesfield, UK) and was funded by GlaxoSmithKline plc. Trademarks are the property of their respective owners., (JCOPDF © 2020.)

Background: Symptoms of chronic obstructive pulmonary disease (COPD) may diminish patients' health-related quality of life (HRQoL). We report effects of Longhala™ Magnair™ (glycopyrrolate) Inhalation Solution, a drug/device combination of the long-acting antimuscarinic glycopyrrolate administered using the eFlow® closed system (eFlow CS) nebulizer, on HRQoL from the Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer (GOLDEN) clinical studies. Methods: Data consisted of a pooled analysis of 2 phase 3, 12-week efficacy studies (GOLDEN-3 and -4) of glycopyrrolate/eFlow CS (25 or 50 mcg twice daily [BID]) versus placebo, and a 48-week, open-label safety study (GOLDEN-5) of glycopyrrolate/eFlow CS 50 mcg BID versus tiotropium 18 mcg once daily in patients with moderate to very severe COPD. Change from baseline in HRQoL was measured via the St George's Respiratory Questionnaire (SGRQ). Results are provided as mean changes in SGRQ Total score and as response analysis (≥4-point improvement [responder], no change, and ≥4-point worsening in Total score) using analysis of covariance or logistic regression, as applicable. Results: Atotal of 1293 patients were evaluated from GOLDEN-3 and -4 and 1086 from GOLDEN-5. Glycopyrrolate/eFlow CS significantly improved SGRQ Total and component scores. The percentage of SGRQ responders in pooled GOLDEN-3/4 was 46.8% for glycopyrrolate/eFlow CS 25 mcg, 41.7% for glycopyrrolate/eFlow CS 50 mcg, and 34.5% for placebo. SGRQ Total and component score improvements were similar between glycopyrrolate/eFlow CS and tiotropium in GOLDEN-5. Conclusions: The drug/device combination of glycopyrrolate/eFlow CS significantly improved HRQoL, as measured by the SGRQ, offering a potential maintenance treatment option in patients with moderate to very severe COPD. ClinicalTrials.gov: NCT02347761, NCT02347774, NCT02276222., Competing Interests: Sunovion Pharmaceuticals Inc., provided funding for this research. G. Ferguson receives consultancy and advisory fees from Sunovion Pharmaceuticals Inc., E.M. Kerwin receives consultancy and advisory fees from Amphastar, AstraZeneca, Mylan, Novartis, Pearl, Sunovion, Teva, and Theravance. He has conducted multicenter clinical research trials for approximately 40 pharmaceutical companies. J. Donohue receives consultancy and advisory fees from Sunovion Pharmaceuticals Inc. R. Tosiello, V Ganapathy, and K. Rajagopalan are full-time employees of Sunovion Pharmaceuticals Inc. V. Bollu was a former full-time employee of Sunovion Pharmaceuticals Inc., and currently receives consultancy fees from Sunovion.