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

Individuals with asthma remain inadequately controlled despite treatment with inhaled corticosteroid and long-acting β2-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.