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ABSTRACT: Background
The safety and efficacy of fixed-dose combination (FDC) of glycopyrronium bromide 12.5 μg/formoterol fumarate 12 μg (GB/FF) twice daily as dry powder inhalers (DPIs) compared to glycopyrronium 50 μg monotherapy (GLY) once daily as DPI in subjects with moderate-to-severe chronic obstructive pulmonary disease (COPD) were evaluated.Methods
This was a phase-3, randomized, double-blind, active-controlled, parallel-group, superiority study conducted in India. COPD patients aged ≥40 to ≤65 years, current or ex-smokers with FEV1/FVC <0.70, using ICS, LAMA, or LABA for ≥1 month were included. Subjects were randomized (1:1) to GB/FF or GLY for 12 weeks. The primary efficacy endpoint was the change from baseline in peak FEV1 at the end of 12 weeks. The study is registered with the Clinical Trials Registry of India (CTRI/2017/02/007814).Results
Between March 2017 and July 2018, 331 patients were enrolled and randomized into GB/FF FDC (165 patients) and GLY monotherapy (166 patients) groups. At week 12, the difference in change from baseline in the peak FEV1 for GB/FF DPI versus GLY was 0.115 L (SE = 0.02; 95% CI = 0.061, 0.170; P < 0.0001). Trough FEV1 increased significantly in the GB/FF group compared to the GLY group with a treatment difference of 0.078 L (SE = 0.02; 95% CI = 0.015, 0.14; P = 0.01). There were no significant differences in adverse events between the groups.Conclusion
FDC of GB/FF (12.5/12 μg twice daily) as a DPI provides superior bronchodilation and lung function improvement over GLY (50 μg once daily) monotherapy. It is safe and well tolerated in symptomatic COPD patients.
SUBMITTER: Salvi S
PROVIDER: S-EPMC9746267 | biostudies-literature | 2022 Nov-Dec
REPOSITORIES: biostudies-literature
Salvi Sundeep S Jain Manish K MK Krishnamurthy Srikanth S Balki Akash A Kodgule Rahul R Tandon Monika M Bhagat Sagar S Panchal Sagar S Khatri Nishtha N Wu Wen W Pendse Amol A Patil Saiprasad S Barkate Hanmant H
Lung India : official organ of Indian Chest Society 20221101 6
<h4>Background</h4>The safety and efficacy of fixed-dose combination (FDC) of glycopyrronium bromide 12.5 μg/formoterol fumarate 12 μg (GB/FF) twice daily as dry powder inhalers (DPIs) compared to glycopyrronium 50 μg monotherapy (GLY) once daily as DPI in subjects with moderate-to-severe chronic obstructive pulmonary disease (COPD) were evaluated.<h4>Methods</h4>This was a phase-3, randomized, double-blind, active-controlled, parallel-group, superiority study conducted in India. COPD patients a ...[more]