Improvements in patient-reported outcomes: A prospective, non-interventional study with aclidinium bromide for treatment of COPD

Background: The inhaled long-acting muscarinic antagonist aclidinium bromide has been shown to significantly improve lung function parameters and symptom severity in patients with COPD in randomised placebo- and active-controlled clinical studies. To obtain a comprehensive view of the treatment effects, patient-reported outcomes were investigated in a real-life COPD population in routine clinical practice in Austria. Methods: Multicentre, prospective, non-interventional study in patients with COPD who were newly initiated on treatment with Eklira (R) Genuair (aclidinium bromide; recommended dose 400 mu g twice daily) as first-line or add-on therapy. Patients were either treatment naive or switched from other COPD medications. Health-related quality of life by means of the COPD Assessment Test(TM) (CAT) and symptom-related variables were evaluated at the first visit (baseline) and after approximately 12 weeks of treatment. Features of the inhaler were assessed by patients and physicians at the follow-up visit. Results: A total of 795 COPD patients (56% male; median age: 64 years) were enrolled and treated. During the observational period, the proportion of patients with at least moderate nighttime symptoms, early-morning symptoms, and limitations in morning activities decreased from 45.0% to 21.4%, from 57.7% to 26.0%, and from 49.9% to 25.3%, respectively. All improvements from baseline in symptom severity and activity limitation were statistically significant (p < 0.0001, all tests). The mean (+/- SD) frequency of nocturnal awakenings decreased from 1.2 (+/- 1.4) to 0.7 (+/- 1.2) times per night (p < 0.0001). Quality of life improved significantly in patients treated with aclidinium bromide over 3 months compared to baseline (p <0.0001; mean CAT total score: 18.5 +/- 7.5 vs. 13.8 +/- 7.3). Up to 90% of the patients and up to 91% of the physicians assessed individual features of the inhaler as 'very good' or 'good'. Aclidinium bromide was well tolerated; 6.9% of the patients reported adverse drug reactions, none of which were serious. Conclusions: This non-interventional study indicated beneficial effects of Eklira (R) Genuair (R) in the treatment of COPD with regard to nighttime and early-morning symptoms, limitation of morning activities, and quality of life under routine conditions. The acceptance of the inhaler device was high, which is a prerequisite to ensure adherence in long-term therapy. (C) 2015 Elsevier Ltd. All rights reserved.