An Open-Label, Single-Arm, Multicentric, Prospective, Phase IV Study to Evaluate the Safety and Effectiveness of Indacaterol/Mometasone/Glycopyrronium Dry Powder Inhaler (DPI) in the Management of Asthma Patients (OASIS Study)

BACKGROUND: Asthma is a global health concern that requires an effective management approach. The OASIS study aims to evaluate the safety and effectiveness of the fixed-dose combination (FDC) of indacaterol acetate, mometasone furoate, and glycopyrronium bromide (IND/MF/GLY) delivered once daily via a dry powder inhaler (DPI) in Indian adults with inadequately controlled asthma, notwithstanding the global evidence supporting its use. METHODS: This 12-week, open-label, single-arm, multicenter phase IV study was conducted on asthmatic patients at five sites in India (All India Institute of Medical Sciences (AIIMS), Bihar; Jeevan Rekha Hospital, Karnataka; Rajarshee Chhatrapati Shahu Maharaj Government Medical College and Chhatrapati Pramila Raje Hospital, Maharashtra; New Leelamani Hospital Pvt Ltd, Kanpur; and Citizen Hospital, Karnataka). The study was approved by the Institutional Ethics Committee of AIIMS (approval no. AIIMS/Pat/EC/2024/1197) and registered with Clinical Trials Registry - India (CTRI: 2023/12/060605). The primary and secondary endpoints were safety and effectiveness, respectively. Effectiveness included changes in lung function, Asthma Control Questionnaire-5 (ACQ-5) score, rescue medication use, treatment satisfaction, and adherence. RESULTS: A total of 182 patients were enrolled in the study, of which 180 (mean age 46.2 ± 12.9 years; 59.9% male) completed the study. Over 12 weeks, treatment-emergent adverse events were minimal (2.7%) with no serious adverse events. Significant improvements were observed in lung function at both week 4 (forced expiratory volume in 1sec (FEV₁): +264.5 ± 53.5 mL; forced vital capacity (FVC): +225.6 ± 18.4 mL) and week 12 (FEV₁: +458.2 ± 66.2 mL; FVC: +522.9 ± 271.8 mL), alongside ACQ-5 score reductions (week 4: -0.71 ± 0.07; week 12: -1.45 ± 0.03). Rescue medication use declined, and adherence remained high (98.4%), with strong patient and physician satisfaction. CONCLUSION: Once-daily IND/MF/GLY FDC DPI demonstrated a favorable safety profile and significant improvement in asthma control in Indian adults.