ArticleCureus2025
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).
Article in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundAsthma 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.
methodsThis 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.
resultsA 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.
conclusionOnce-daily IND/MF/GLY FDC DPI demonstrated a favorable safety profile and significant improvement in asthma control in Indian adults.
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