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