Improvement in health status with once-daily indacaterol/glycopyrronium 110/50\xa0\u03bcg in COPD patients: real-world evidence from an observational study in Ireland

Abstract

AimsIndacaterol/glycopyrronium (IND/GLY) 110/50 μg is a once-daily (o.d.) fixed-dose combination of long-acting β2-agonist/long-acting muscarinic antagonist approved in over 90 countries, including Ireland, for the management of COPD. The present study was conducted to evaluate health status of COPD patients, initiated on IND/GLY 110/50 μg o.d., using the Clinical COPD Questionnaire (CCQ) tool in a real-world primary care setting in Ireland.MethodsThis was a real-world, prospective, open-label study. COPD patients aged > 40 years and with a smoking history of > 10 pack-years were included and switched to once-daily IND/GLY 110/50 μg. Enrolment of patients into the study occurred only after the decision had been made by the physician to prescribe IND/GLY 110/50 μg. Data were collected at baseline and Week 26. Health status was assessed using the validated CCQ.ResultsA total of 200 patients were included in study. The mean CCQ total score decreased from 2.36 at baseline to 1.44 at Week 26 (Δ, 0.92; P < 0.0005). Of the 156 patients who completed study, 113 (72.4%) achieved minimum clinically important difference in CCQ total score with IND/GLY 110/50 μg. CCQ domain scores also decreased during the study. Improvement in health status was observed across all GOLD groups and irrespective of prior COPD treatment. Adverse events were reported by 20% of patients with COPD exacerbation/infected COPD being the most common AE, reported by 11 patients.ConclusionsIn real-life clinical practice in Ireland, IND/GLY 110/50 μg o.d. demonstrated statistically significant and clinically important improvement in health status in patients with COPD.