Improved Health Related Quality of Life Outcomes in Subjects With Moderate to Severe COPD Treated With Nebulized Arformoterol Tartrate: Results From a 52-Week Trial

Abstract

PURPOSE: Chronic obstructive pulmonary disease (COPD) is a complex disease with multiple symptoms that negatively impact patients' health related quality of life (HRQoL). METHODS: In this multicenter, placebo controlled, double blind, parallel‐group, 52‐week safety trial, subjects were randomly assigned to arformoterol (ARF) 15mugBID (N=420) or placebo (N=421). Treatment with other non‐LABA COPD medications was permitted. Inclusion criteria included: COPD diagnosis with a forced expiratory volume in one second (FEV1) < 50% of predicted, FEV1>0.50 L, and FEV1/forced vital capacity (FVC) ratio of < 70% at screening or randomization, age > 40 years, smoking history > 15 pack years, and a baseline breathlessness severity grade > 2. Primary endpoint was time to COPD‐related events: respiratory death or COPD exacerbation‐hospitalizations. As a secondary efficacy endpoint, St. George's Respiratory Questionnaire (SGRQ), a validated 50‐item self‐administered instrument was used to measure HRQoL at randomization, months 3, 6, and 12. The SGRQ yields a total score and subscale scores for symptoms, activities, and impacts. SGRQ scores range from 0 ‐ 100, with higher scores indicating worse health status. A 4‐unit improvement in total score is clinically significant. Outcomes were analyzed using a mixed model for repeated measures (MMRM). RESULTS: At baseline, mean age was 63.8 years, 43% were female, and 51% were current smokers, with baseline total SGRQ score of 53.09 and 54.79 for the ARF and placebo, respectively. A total of 466 subjects, including 211 (50.7%) placebo‐treated and 255 (60.7%) ARF‐treated group completed the trial. ARF‐treated subjects had greater improvements vs. placebo on total score (LS means ‐4.24 vs. ‐2.02; p = 0.006), symptoms domain (p=0.015), and impacts domain (p = 0.001), but not the activity domain (p = 0.052) across the post‐baseline trial visits. Adjusted odds ratio for achieving the 4‐unit improvement in SGRQ total score ranged from 0.75‐0.88 across the visits, favoring ARF. CONCLUSIONS: In this 52‐week trial, treatment with arformoterol tartrate improved HRQoL over placebo.