SESSION TITLE: COPD Treatment Posters
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PM
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) 15µgBID (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.
CLINICAL IMPLICATIONS: Measuring HRQoL along with lung function helps to evaluate the overall effectiveness of a COPD maintenance treatment.
DISCLOSURE: James Donohue: Consultant fee, speaker bureau, advisory committee, etc.: Sunovion Pharmaceuticals, Inc Vamsi Bollu: Employee: Sunovion Pharmaceuticals, Inc. Nicola Hanania: Consultant fee, speaker bureau, advisory committee, etc.: Sunovion Pharmaceuticals, Inc, Grant monies (from industry related sources): Sunovion Pharmaceuticals, Inc
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