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

AIMS: Indacaterol/glycopyrronium (IND/GLY) 110/50 µg is a once-daily (o.d.) fixed-dose combination of long-acting ß2-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. METHODS: This 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. RESULTS: A 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. CONCLUSIONS: In 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.