title: Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials.
abstract: BACKGROUND
  Cough and sputum are troublesome symptoms in chronic obstructive pulmonary disease (COPD) and are associated with adverse outcomes. The efficacy of aclidinium bromide 400 µg twice daily in patients with stable COPD has been established in two phase III studies (ACCORD COPD I and ATTAIN) and a phase IIIb active-comparator study. This analysis evaluated cough-related symptoms across these studies.
  
  
  METHODS
  Patients were randomised to placebo, aclidinium 200 µg or 400 µg twice daily in ACCORD (12 weeks) and ATTAIN (24 weeks), or to placebo, aclidinium 400 µg twice daily or tiotropium 18 µg once daily (6-week active-comparator study). Analysed end points included changes from baseline in Evaluating Respiratory Symptoms (E-RS; formerly known as EXAcerbations of Chronic pulmonary disease Tool), total and cough/sputum scores and frequency/severity of morning and night-time cough and sputum symptoms.
  
  
  RESULTS
  Data for 1792 patients were evaluated. E-RS cough/sputum domain scores were significantly reduced with aclidinium 400 µg versus placebo in ATTAIN (-0.7 vs -0.3, respectively; p<0.01) and the active-comparator study (-0.6 vs -0.2, respectively; p<0.01). In the active-comparator study, significantly greater improvements were observed with aclidinium versus placebo for severity of morning cough (-0.19 vs -0.02; p<0.01) and phlegm (-0.19 vs -0.02; p<0.05). In ACCORD, aclidinium reduced night-time cough frequency (-0.36 vs 0.1 for placebo; p<0.001) and severity (-0.24 vs -0.1 for placebo; p<0.05), and frequency of night-time sputum production (-0.37 vs 0.05 for placebo; p<0.001).
  
  
  CONCLUSIONS
  Aclidinium 400 µg twice daily improves cough and sputum expectoration versus placebo in stable COPD.
  
  
  BACKGROUND
  NCT00891462; NCT01001494; NCT01462929.
authors.affiliation: Centre for Infection and Immunity, Queen's University Belfast , Belfast , UK.
authors.forename: Lorcan
authors.initials: L
authors.lastname: McGarvey
authors.affiliation: Hull York Medical School, University of Hull, Castle Hill Hospital , Cottingham , UK.
authors.forename: Alyn H
authors.initials: AH
authors.lastname: Morice
authors.affiliation: Centre for Respiratory Medicine and Allergy, University of Manchester, University Hospital of South Manchester , Manchester , UK.
authors.forename: Jaclyn A
authors.initials: JA
authors.lastname: Smith
authors.affiliation: Division of Asthma, Allergy and Lung Biology , King's College London , London , UK.
authors.forename: Surinder S
authors.initials: SS
authors.lastname: Birring
authors.affiliation: R&D Centre, AstraZeneca PLC , Barcelona , Spain.
authors.forename: Ferran
authors.initials: F
authors.lastname: Chuecos
authors.affiliation: R&D Centre, AstraZeneca PLC , Barcelona , Spain.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Seoane
authors.affiliation: R&D Centre, AstraZeneca PLC , Barcelona , Spain.
authors.forename: Diana
authors.initials: D
authors.lastname: Jarreta
keywords: COPD Pharmacology; Cough/Mechanisms/Pharmacology