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

Abstract

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<0.001; 95% confidence interval: 17.6–23.9). Compared with nonresponders, responders were more likely current smokers (55.52% vs 44.02%, P=0.0021) and had more severe COPD (forced expiratory volume in 1 second [FEV₁]: 1.16 vs 1.23 L, P=0.0419), more exacerbations (0.96 vs 0.69, P=0.0018), and worse mean SGRQ Total (59.81 vs 40.57, P<0.0001), Clinical COPD Questionnaire (3.29 vs 2.05, P<0.0001), and Modified Medical Research Council Dyspnea Scale (3.13 vs 2.75, P<0.0001) scores. Arformoterol-receiving responders exhibited significantly greater improvements in FEV₁ (0.09 vs 0.008, P=0.03) and fewer hospitalizations (0.13 vs 0.24, P=0.02) than those receiving placebo.

Conclusion

In this study, arformoterol treatment significantly improved HRQoL reflected by SGRQ. For the analysis performed on these data, arformoterol may be particularly effective in improving lung function and reducing hospitalizations among patients who are unable to quit smoking or present with more severe symptoms.

Keywords:

• St George’s Respiratory Questionnaire
• growth mixture model
• HRQoL
• long-acting beta agonist

Acknowledgments

The study was funded by Sunovion Pharmaceuticals Inc. The authors wish to thank Claudette Knight, PharmD, and D. Michele Nikoloff, PhD, of Percolation Communications LLC for providing medical editorial assistance. Development of this manuscript was sponsored by Sunovion Pharmaceuticals Inc.

Disclosure

JFD receives consultancy and advisory fees from Sunovion Pharmaceuticals Inc. MDS is a full-time employee and sole stockholder in Agile Outcomes Research, Inc., a research consulting firm contracted by Sunovion Pharmaceuticals Inc. to assist with this research. DES, LMN, and VSLW are employees of RTI Health Solutions, a research consulting firm contracted by Sunovion Pharmaceuticals Inc. to assist with this research. RTI Health Solutions is a research unit of RTI International, a not-for-profit research institute. At the time of this research, VKB was an employee of Sunovion Pharmaceuticals Inc. NAH has served as a consultant for Sunovion Pharmaceuticals Inc., and his institution has received research grant funding on his behalf. The authors report no other conflicts of interest in this work.

Author contributions

All authors have contributed substantially to the design of the study, acquisition, analysis, and interpretation of data and to the drafting of the manuscript or revising it critically and gave final approval of the version to be submitted.