Clinical Effectiveness And Safety Of Glycopyrronium In Chronic Obstructive Pulmonary Disease And Asthma Copd Overlap: Acos Study
Volume 4 - Issue 5, May 2020 Edition
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Prabhudesai PP , Singh BP, Bhattacharya PS, Katiyar S, Korukonda K
Asthma COPD Overlap, Chronic obstructive pulmonary disease, frequent exacerbator, Glycopyrronium, Non-smoker.
Introduction: The burden of Asthma-COPD Overlap (ACO) Syndrome is evolving especially in light of growing burden for nonsmoking risk factors in India. Glycopyrronium add on therapy offers quick and complimentary bronchodilation and anti-inflammatory actions in poorly controlled COPD or ACO. Material and Methods: A prospective, observational, case control, drug utilization study was conducted at four centers during Janâ€™ to Decâ€™ 18 for COPD and ACO cases defined as per GOLD and Roundtable ATS recommendations respectively were enrolled in 1:1 ratio at four centers after IRB approval, written informed consent and Clinical trial registry of India registration (CTRI/2017/09/009845). A study sample size (n=160) was based on assessment of primary endpoint for a pre-bronchodilator FEV1 difference of 50% between the two groups of ACO and COPD receiving Glycopyrronium add on therapy compared to baseline values at 12 weeks with a dropout rate of 25% Results: 128 COPD (n=64) and ACO (n=64) cases with at least one prior exacerbation were randomized to Glycopyrronium (50 mcg, once a day) â€˜add-onâ€™ with FORM6/BUD200 mcg, twice a day for 12 weeks. Baseline demographics, Male/Female (119/09); Age 59.9ï‚±11.1y; Wt 59.1ï‚±13.7kg; FEV1 49.9%ï‚±15.8; Exacerbation â‰¥2/y, [82(64%)]; CAT (19.4ï‚±8.3); Smoker (90, 70.3%), Non-smoker (38, 29.7%). prebronchodilator FEV1 improvement difference between COPD and ACO groups met the pre-defined difference of ï‚³50% improvement at 12 weeks as 6.4ï‚±12.4% (127.1ï‚±248 ml, p<0.03). Post-hoc analyses for COPD and ACO Smoker frequent exacerbators showed prebronchodilator FEV1 (change) 123.2ï‚±356.4 ml (p<0.0001) and 320.9ï‚±335.3 ml (p<0.0001) respectively. In COPD and ACO non-smoker frequent exacerbators pre-dose FEV1 (change) of 216.2ï‚±354.9 ml (p=0.001) and 402.3ï‚±406.1 ml (p=0.02) was observed respectively. Intent to treat analyses showed TEAEs (7, 4.3%) of mild to moderate intensity with none requiring any treatment withdrawal. Conclusion: Glycopyrronium 50 mcg â€˜add-onâ€™ therapy offers incremental bronchodilation that is meaningfully clinically significant (MCID) in poorly controlled symptomatic Severe COPD and ACO.
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