Comparative Study on the effectiveness of Glycopyrrolate/Formoterol versus Tiotropium/Formoterol in patients with Chronic Obstructive Pulmonary Disease

BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) has several implications on health, lifestyle, and economic burden. Combinational therapy using muscarinic antagonists and beta-(2) agonists has long been warranted for use as maintenance therapy. A lack of studies directly comparing Glycopyrrolate/Formoterol (GFF) versus Tiotropium/Formoterol (TFF) was observed which led us to analyze the effectiveness of these combinations. METHODS: In this pilot, prospective, randomized, open-label, parallel-arm, 12-week period study, 60 patients with COPD (moderate-severe) were randomized in a 1:1 ratio to receive either GFF or TFF (n = 30 each). The primary outcome was to demonstrate non-inferiority between the two groups concerning FEV(1) for 12 weeks. The secondary outcome was the assessment of the ratio of FEV(1)/FVC and state of health evaluation by St. George's Respiratory Questionnaire (SGRQ). RESULTS: Out of 60 participants, 58 subjects completed the study. At week 12, the mean and standard deviation value of FEV(1) between groups were 1.49 ± 0.38 and 1.38 ± 0.30 (p > 0.05) and FEV(1)/FVC ratio were 0.67 ± 0.09 and 0.74 ± 0.08 (p < 0.01) respectively. A significant difference was observed in the FEV(1) and FEV(1)/FVC values in comparison with baseline versus last follow up in both the groups (p < 0.01). However, no remarkable variation was identified in the FEV(1) values over the two groups. The health status assessment by SGRQ showed significant improvement in both groups after the treatment. CONCLUSION: Non-inferiority of GFF when compared to TFF was established along with good tolerability and comparable adverse effect profile.