International Journal of Advanced Research and Publications (2456-9992)

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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Author(s)
Prabhudesai PP , Singh BP, Bhattacharya PS, Katiyar S, Korukonda K
Keywords
Asthma COPD Overlap, Chronic obstructive pulmonary disease, frequent exacerbator, Glycopyrronium, Non-smoker.
Abstract
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 Jan’ to Dec’ 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) ‘add-on’ with FORM6/BUD200 mcg, twice a day for 12 weeks. Baseline demographics, Male/Female (119/09); Age 59.911.1y; Wt 59.113.7kg; FEV1 49.9%15.8; Exacerbation ≥2/y, [82(64%)]; CAT (19.4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 50% improvement at 12 weeks as 6.412.4% (127.1248 ml, p<0.03). Post-hoc analyses for COPD and ACO Smoker frequent exacerbators showed prebronchodilator FEV1 (change) 123.2356.4 ml (p<0.0001) and 320.9335.3 ml (p<0.0001) respectively. In COPD and ACO non-smoker frequent exacerbators pre-dose FEV1 (change) of 216.2354.9 ml (p=0.001) and 402.3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 ‘add-on’ therapy offers incremental bronchodilation that is meaningfully clinically significant (MCID) in poorly controlled symptomatic Severe COPD and ACO.
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