EC Pulmonology and Respiratory Medicine

Introduction: Obstructive Airway Diseases (OADs) are the leading cause of death among chronic respiratory diseases worldwide, highlighting the urgent need for novel therapies. The combination of fluticasone furoate/vilanterol/glycopyrronium (FF/VI/GLY), a once-daily single inhaler triple therapy (SITT), has been recently introduced in India. However, there is currently no published real-world data available either from India or globally on the utilization of this novel regimen. Given the limited clinical experience with FF/VI/GLY in the Indian context, it is essential to systematically evaluate its real-world utilization, including its preference, prescribing patterns and clinical characteristics of patients.

Methodology: This retrospective, observational drug utilisation study at 360 outpatient clinics in India from July 2024 to December 2024. Prescription data and medical history of patients who were prescribed the FF/VI/GLY combination were collected. Ethics approval was obtained from an independent ethics committee prior to study initiation.

Results: FF/VI/GLY DPI was prescribed for COPD (49%), asthma (28.8%), and ACOS (20.8%). A total of 60.45% were switched from prior therapies-mainly ICS/LABA (35.03%) and LABA/LAMA (35.60%)-while 39.56% were treatment-naïve. Most COPD patients fell under GOLD Group E (53.7%) and Group B (36.4%), with a mean CAT score of 19.8 ± 8.1. Asthma patients were mainly in GINA Step 3 (33.6%) and Step 4 (26.5%), with a mean ACQ-5 score of 1.9 ± 1.2. Mean FEV₁% predicted was 45.65 ± 22.03%, with 61.87% of COPD patients showing very severe obstruction (GOLD 4). The average exacerbation rate was 2.2 per year; 68.8% of patients were hospitalized, and 41% had at least two exacerbation-related admissions. Common comorbidities included cardiovascular disease (40.9%), GERD (30.3%), and diabetes (29.7%).

Conclusion: This real-world study highlights a high symptom burden, frequent exacerbations, and severe airflow limitation in patients prescribed FF/VI/GLY DPI across India. The switch from prior therapies reflects a growing clinical preference for once-daily SITT in managing moderate-to-severe COPD, asthma, and ACOS, especially in multi-morbid patients.

 Keywords: Chronic Respiratory Diseases (CRDs); Obstructive Airway Diseases (OAD); Interstitial Lung Disease (ILD); Fluticasone Furoate/Vilanterol/Glycopyronnium (FF/Vi/GLY)

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