Rationale: Asthma, a chronic airways disease that affects nearly 18% of the global population, necessitates adherence to medication for effective long-term management. Over the past decade, two new once-daily fixed-dose combinations (FDC) of inhaled corticosteroids (ICS) and long-acting β2-adrenoceptor agonists (LABA), such as fluticasone furoate/vilanterol (FF/VI) and mometasone furoate/indacaterol (MF/IND), have been introduced which aim to enhance treatment adherence. This meta-analysis aims to study the efficacy and safety of once-daily versus twice-daily administration of ICS/LABA FDCs in patients with moderate-to-severe asthma.

Methods: Using a predefined PICO (Patient problem, Intervention, Comparison, and Outcome) framework, a systematic literature search was conducted to identify randomized clinical trials (RCTs) with a minimum duration of 24 weeks. The objective of the search was to compare the efficacy and safety of once-daily versus twice-daily administered ICS/LABA combinations in patients with moderate-to-severe asthma. The search focused on outcomes such as the change from baseline in trough forced expiratory volume in 1 second (FEV1), the proportion of patients achieving asthma control, the rate of severe exacerbations, and safety profile.

Results: The analysis included five randomized clinical trials (RCTs), with a total of 5,414 participants. Findings revealed that once-daily administration of ICS/LABA treatment yielded significant improvements in trough forced expiratory volume in 1 second (FEV1) (Mean Difference = 0.03L, p<0.0001) and reduced incidence of severe exacerbations (Incidence Rate Ratio = 0.80, p=0.0161) when compared to twice-daily administration. Additionally, once-daily treatment demonstrated similar efficacy in controlling asthma symptoms (Odds Ratio = 1.10, p=0.13). Moreover, there were no notable differences in the incidence of adverse events, serious adverse events, or adverse events of special interest observed between the two fixed-dose combinations (FDCs).

Conclusion: Once-daily ICS/LABA combinations demonstrated significant benefits in adults with moderate-to-severe asthma, including a notable reduction in exacerbations, improvement in lung function, and comparable control of asthma symptoms and safety profile when compared to twice-daily ICS/LABA combinations.

American Thoracic Society (ATS) 2023 International Conference, 19th May - 24th May 2023, Washington DC.