Comparative Study on the Effectiveness of Glycopyrrolate/Formoterol Versus Tiotropium/Formoterol in Patients with Chronic Obstructive Pulmonary Disease

Overview

Journal Contemp Clin Trials Commun

Date 2022 Jun 16

PMID 35707484

Authors

Nalini Jayanthi

Karthickeyan Krishnan

Manali Sudhir

S Girija

Nishi P A

Sathish Kumar J

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Comparing Glycopyrronium/Formoterol Combination Therapy With Monotherapy in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD): A Narrative Review.

Prada B, Jadhav U, Ghewade B, Wagh P, Karnan A, Ledwani A Cureus. 2024; 16(4):e58633.

PMID: 38770495 PMC: 11103448. DOI: 10.7759/cureus.58633.

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