Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM): a double-blind, randomised, crossover, placebo-controlled, single-centre trial

This study is registered with ClinicalTrials.gov, number NCT02442206. Findings Between May 18, 2015, and April 20, 2017, we randomly assigned 62 eligible participants to treatment; 30 to indacaterol–glycopyrronium followed by placebo and 32 to placebo followed by indacaterol–glycopyrronium. The 62 randomly assigned patients were included in the intent-to-treat analysis. There were two protocol violations and therefore 60 were included in the per-protocol analysis. 57 patients completed both treatment periods. After indacaterol–glycopyrronium treatment, left-ventricular end-diastolic volume increased from a mean 55·46 mL/m2 (SD 15·89) at baseline to a least-squares (LS) mean of 61·76 mL/m2 (95% CI 57·68–65·84), compared with a change from 56·42 mL/m2 at baseline (13·54) to 56·53 mL/m2 (52·43–60·62) after placebo (LS means treatment difference 5·23 mL/m2 [95% CI 3·22 to 7·25; p<0·0001]). The most common adverse events reported with indacaterol–glycopyrronium were cough (in nine patients [15%] of 59) and throat irritation (in seven [12%]). With placebo, the most common adverse events reported were headache (in five patients [8%] of 61) and upper respiratory tract infection (in four [7%]). Two patients had serious adverse events: one (2%) after indacaterol–glycopyrronium (endometrial cancer) and one (2%) after placebo (myocardial infarction); these were not thought to be treatment related. No patients died during the study. Interpretation This...
Source: The Lancet Respiratory Medicine - Category: Respiratory Medicine Source Type: research