ABSTRACT
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 FEV1 for 12 weeks. The secondary outcome was the assessment of the ratio of FEV1/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 FEV1 between groups were 1.49 ± 0.38 and 1.38 ± 0.30 (p > 0.05) and FEV1/FVC ratio were 0.67 ± 0.09 and 0.74 ± 0.08 (p < 0.01) respectively. A significant difference was observed in the FEV1 and FEV1/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 FEV1 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.
