Long-term health-related quality-of-life and symptom response profiles with arformoterol in COPD: results from a 52-week trial

James F Donohue,1 Vamsi K Bollu,2 Donald E Stull,3 Lauren M Nelson,4 Valerie SL Williams,4 Michael D Stensland,5 Nicola A Hanania6 1Department of Pulmonary Diseases and Critical Care Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, 2Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb, Princeton, NJ, 3Data Analytics and Design Strategy, 4Psychometrics, RTI Health Solutions, Research Triangle Park, NC, 5Agile Outcomes Research, Inc., Rochester, MN, 6Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA Background: Symptom severity is the largest factor in determining subjective health in COPD. Symptoms (eg, chronic cough, dyspnea) are associated with decreased health-related quality of life (HRQoL). We evaluated the impact of arformoterol on HRQoL in COPD patients, measured by St George’s Respiratory Questionnaire (SGRQ). Post hoc growth mixture model (GMM) analysis examined symptom response profiles. Methods: We examined data from a randomized, double-blind, parallel-group, 12-month safety trial of twice-daily nebulized arformoterol 15 µg (n=420) versus placebo (n=421). COPD severity was assessed by Global Initiative for Chronic Obstructive Lung Disease (GOLD) status. GMM analysis identified previously unknown patient subgroups and examined the heterogeneity in response to SGRQ Symptoms scores. Results: SGRQ Total score improved by 4.24 points with arformoterol and 2.02 points with placebo (P=0.006). Significantly greater improvements occurred for arformoterol versus placebo in SGRQ Symptoms (6.34 vs 4.25, P=0.031) and Impacts (3.91 vs 0.97, P=0.001) scores, but not in Activity score (3.57 vs 1.75, P=0.057). GMM identified responders and nonresponders based on the SGRQ Symptoms score. End-of-study mean difference in SGRQ Symptoms scores between these latent classes was 20.7 points (P