title: Improvements in patient-reported outcomes: A prospective, non-interventional study with aclidinium bromide for treatment of COPD.
abstract: 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® Genuair® (aclidinium bromide; recommended dose 400 μg twice daily) as first-line or add-on therapy. Patients were either treatment naïve or switched from other COPD medications. Health-related quality of life by means of the COPD Assessment Test™ (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® Genuair® 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.
authors: Karl Landsteiner Institute for Clinical and Experimental Pneumology, Hietzing Hospital, Wolkersbergenstraße 1, 1130 Vienna, Austria.
authors: Katharina
authors: K
authors: Marth
authors: Almirall GmbH, Breitenfurter Straße 113, 1120 Vienna, Austria.
authors: Elisabeth
authors: E
authors: Schuller
authors: Karl Landsteiner Institute for Clinical and Experimental Pneumology, Hietzing Hospital, Wolkersbergenstraße 1, 1130 Vienna, Austria. Electronic address: wolfgang.pohl@wienkav.at.
authors: Wolfgang
authors: W
authors: Pohl
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D058995:Dry Powder Inhalers / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000473:pathology; D011788:Quality of Life; D057566:Self Report; D016896:Treatment Outcome; D014326:Tropanes / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D018727:Muscarinic Antagonists; D014326:Tropanes; C542859:aclidinium bromide
keywords: Aclidinium bromide; COPD; Morning symptoms; Non-interventional study; Quality of life