Brian O'Doherty1, Jane Dorman2, Karen McGrath3, Kevin Kelly4, David Molony5, Seán Lacey6, Sarah Whelan7, Simon Schmid8, Shane Sullivan9. 1. Gorey Medical Centre, Conal House, St. Michaels Road Gorey, Co. Wexford, Ireland. 2. 6 The Mall, Rathquarter, Sligo, Ireland. 3. SantryGP.ie Clinic, Unit 1 Northwood House, Northwood Business Park, Santry, Dublin, Ireland. 4. Western House Medical Centre, Western Rd, Clonmel, Co. Tipperary, Ireland. 5. The Red House Family Practice, Mallow, Co. Cork, Ireland. 6. Department of Mathematics, Cork Institute of Technology, Rossa Avenue, Bishopstown, Cork, T12 P928, Ireland. 7. Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, D04 A9N6, Ireland. 8. Sandoz AG, Square 3, Novartis Campus, Fabrikstrasse 2, 4056, Basel, Switzerland. 9. Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, D04 A9N6, Ireland. shane.sullivan@novartis.com.
Abstract
AIMS: Indacaterol/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. 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.
AIMS: Indacaterol/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 COPDpatients, 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. COPDpatients 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.
Entities:
Keywords:
CCQ; COPD; Health status; Indacaterol/glycopyrronium; Ireland; Real-world
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