COMPARATIVE EFFICACY AND ADVERSE EFFECTS OF INDACATEROL-GLYCOPYRRONIUM VS. SALMETEROL-FLUTICASONE IN COPD MANAGEMENT: A RANDOMIZED CONTROLLED TRIAL

Main Article Content

Mohd Irfan Ali Khan
Mohd Shadab
Saquib Reyaz Khan
Bharath Kumar

Keywords

COPD, Indacaterol-Glycopyrronium, Salmeterol-Fluticasone, FEV1, FVC, CAT Score, Adverse Effects

Abstract

Background: Chronic Obstructive Pulmonary Disease (COPD) remains a significant public health concern with multiple therapeutic options available. This study aims to compare the efficacy and safety of two long-acting bronchodilators, Indacaterol-Glycopyrronium (Group A) and Salmeterol-Fluticasone (Group B), in the management of COPD.


Methods: This was a single-center, randomized, active-controlled, open-label study conducted at the Varun Arjun Medical & Rohilkhand Hospital, Shahjahanpur, India. Sixty patients were allocated to each treatment group. Primary outcomes included changes in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC). Secondary outcomes were changes in the COPD Assessment Test (CAT) score and the occurrence of adverse effects. The study was approved by the Institutional Review Board and followed the Helsinki Declaration guidelines.


Results: Both treatments led to statistically significant improvements in FEV1 and FVC, with p-values of 0.205 and 0.169, respectively. The CAT score also improved significantly in both groups (p=0.083). Adverse effects were minimal and comparable between the two groups.


Limitations: The study was conducted at a single center and had a relatively small sample size. The open-label design and short follow-up period of 12 weeks may also affect the generalizability of the findings.


Conclusion: Both Indacaterol-Glycopyrronium and Salmeterol-Fluticasone were effective in improving lung function parameters and the quality of life in COPD patients, with minimal adverse effects. No significant difference in efficacy or safety was noted between the two treatments. Future multi-centric trials with larger sample sizes are recommended

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