Health Status of Patients with Moderate to Severe COPD after Treatment with Nebulized Arformoterol Tartrate or Placebo for 1 Year

作者：Donohue James F; Ganapathy Vaidyanathan; Bollu Vamsi; Stensland Michael D; Nelson Lauren M

来源：Clinical Therapeutics, 2017, 39(1): 66-74.

DOI：10.1016/j.clinthera.2016.11.021

• arformoterol tartrate
• Clinical COPD Questionnaire
• COPD

Purpose: Chronic obstructive pulmonary disease (COPD) is a progressive disease that impairs both objectively measured lung function and patient reported health status. In a randomized clinical trial of patients with moderate to severe COPD, we compared changes in health status after adding arformoterol tartrate or placebo to patients' treatment regimens.
Methods: In this multicenter, double-blind trial, patients were randomized to receive nebulized arformoterol 15 jig BID (n = 420) or matched placebo (n = 421). Treatment with other COPD medications was permitted, except for long-acting 132-agonists. Inclusion criteria were a forced expiratory volume in 1 second (FEV1) 65% of predicted, FEV1>0.50 L, age >= 40 years, smoking history >= 15 pack-years, and a baseline breathlessness severity grade >= 2. The Clinical COPD Questionnaire (CCQ) was used to measure health status at randomization and at months 3, 6, and 12. CCQ scores range from 0 to 6, with higher scores indicating worse health status, and a decrease from baseline in total score by 0.4 point is considered clinically significant. Outcomes were analyzed by using mixed models for repeated measures.
Findings: At baseline, patients' mean age was 63.8 years; 42.9% of patients were female, and 51.4% were current smokers. The mean baseline CCQ total scores were 2.88 and 2.91 for the arformoterol and placebo groups, respectively. A total of 841 patients were randomized to receive either arformoterol (n = 420) or placebo (n = 421); among them, 211 (50.1%) who received placebo and 255 (60.7%) who received arformoterol completed the trial. Arformoterol-treated patients had greater mean improvement from baseline in CCQ total score (-0.18 vs 0.02; P = 0.001), symptoms (-0.21 vs 0.01; P = 0.002), functional state (-0.15 vs 0.02; P = 0.018), and mental state (-0.18 vs 0.02; P = 0.023) than patients receiving placebo. At study end, 38.3% of the arformoterol-treated patients and 30.8% of patients receiving placebo reported clinically significant improvements on the CCQ (P = 0.026). These improvements were only modestly correlated with improvements in FEV1 (r = -0.15; P<0.01).

• 出版日期2017-1