RT Journal Article SR Electronic T1 Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials JF BMJ Open Respiratory Research JO BMJ Open Resp Res FD British Thoracic Society SP e000148 DO 10.1136/bmjresp-2016-000148 VO 3 IS 1 A1 McGarvey, Lorcan A1 Morice, Alyn H A1 Smith, Jaclyn A A1 Birring, Surinder S A1 Chuecos, Ferran A1 Seoane, Beatriz A1 Jarreta, Diana YR 2016 UL http://bmjopenrespres.bmj.com/content/3/1/e000148.abstract AB 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.Method 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.Trial registration numbers NCT00891462; NCT01001494; NCT01462929.