A Prospective Observational Real-World Study to Assess the Effectiveness and Safety of Single-Inhaler Triple Therapy with Glycopyrrolate/Formoterol Fumarate/Budesonide in Patients with Uncontrolled Asthma

OBJECTIVES: -agonist (ICS/LABA) therapy. Single-inhaler triple therapy (SITT) combining ICS, LABA, and long-acting muscarinic antagonist (LAMA) offers a practical treatment escalation option. This study aims to assess the real-world effectiveness, safety, and adherence of SITT with budesonide/glycopyrrolate/formoterol fumarate in adults with uncontrolled asthma. MATERIALS AND METHODS: This multicentric, prospective, observational study was conducted across five centers in India. Adults with uncontrolled asthma on stable ICS/LABA therapy who were prescribed SITT as part of routine care were followed for 12 weeks. Changes in lung function, asthma control (ACT), and quality of life (Mini-AQLQ) were assessed. Medication adherence, adverse events, and asthma exacerbations were recorded. RESULTS: Of 258 enrolled patients, 231 were included in the final analysis. Spirometry measurements showed notable improvements before and after bronchodilator use (all p < 0.001). These included higher MMEF values, suggesting improved small-airway function. Mean ACT scores improved from 14.29 at baseline to 18.49 at follow-up. Mini-AQLQ scores also improved over 12 weeks, indicating better patient-reported quality of life. Medication adherence was high, and no asthma exacerbations, adverse events, or serious adverse events were reported during follow-up. CONCLUSION: In routine practice, SITT BGF was associated with short-term improvements in lung function, asthma control, and QoL in adults with uncontrolled asthma. The mean ACT improved to partially controlled range at 12 weeks. Results suggest short-term effectiveness and tolerability, but longer-term and comparative studies are needed.