COMPARATIVE EFFICACY AND ADVERSE EFFECTS OF INDACATEROL-GLYCOPYRRONIUM VS. SALMETEROL-FLUTICASONE IN COPD MANAGEMENT: A RANDOMIZED CONTROLLED TRIAL
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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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Mohd Irfan Ali Khan
Assistant Professor, Department of Respiratory Medicine, Varun Arjun Medical College & Hospital, Shahjahanpur, India
Mohd Shadab
Assistant Professor, Department of Pharmacology, Varun Arjun Medical College & Hospital, Shahjahanpur, India
Saquib Reyaz Khan
Assitant Professor, Department of Otolaryngiology, Varun Arjun Medical College & Hospital, Shahjahanpur, India
Bharath Kumar
Assistant Professor, Department of Pharmacology, Varun Arjun Medical College & Hospital, Shahjahanpur, India