Adding Umeclidinium to ICS/LABA Improves Lung Function, Exacerbation Rate in Asthma

Patients with asthma that is poorly controlled by inhaled corticosteroids (ICS)/long-acting β₂-agonist (LABA) therapy may experience improvement in lung function with the addition of umeclidinium and/or doubling of the corticosteroid fluticasone furoate (FF) dose, according to study results presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, held virtually from November 13 to 15.

Investigators of this double-blind phase 3A trial randomly assigned adults with uncontrolled asthma despite ICS/LABA therapy to once-daily FF/vilanterol (FF/VI) at 100/25 µg (n=379) or 200/25 µg (n=385) or FF/umeclidinium (UMEC)/VI at 100/62.5/25 µg (n=390) or 200/62.5/25 µg (n=391).

The primary end point of the study included the change from baseline to week 24 in trough forced expiratory volume in 1 second (FEV₁). A secondary end point was the annualized moderate/severe exacerbation rate from weeks 1 through 52 stratified by severe exacerbations in the previous year (0 vs ≥1).

Approximately 16% of patients had at least 2 severe exacerbations in the previous year, whereas the majority (63%) of patients had at least 1 severe exacerbation in the previous year. The addition of UMEC to FF/VI correlated with improvements in trough FEV₁ by week 24 (mean difference in change from baseline with UMEC/FF/VI 100/62.5/25 µg vs FF/VI 100/25 µg, +110; 95% CI, 66-153) improvements in the annualized moderate/severe exacerbation rate ratio (UMEC/FF/VI 100/62.5/25 µg vs FF/VI 100/25 µg, +0.78; 95% CI, 0.61-1.01).

Furthermore, adding UMEC and increasing the FF dose led to improvements in trough FEV₁ by week 24 (mean difference in change from baseline with FF/UMEC/VI 200/62.5/25 µg vs FF/VI 100/25 µg, +143; 95% CI, 100-187) and well as the annualized moderate/severe exacerbation rate ratio (FF/UMEC/VI 200/62.5/25 µg vs FF/VI 100/25 µg, +0.63; 95% CI, 0.49-0.82).

In the subgroup of patients with a history of severe exacerbations, the exacerbation rate improved from 0.93 (95% CI, 0.75-1.15) for FF/VI to 0.72 (95% CI, 0.57-0.91) following the addition of UMEC or increasing FF dose. The investigators also noted that the doubling of the ICS dose improved trough FEV₁ as well as the exacerbation rate irrespective of the patient’s exacerbation history.

Reference

Oppenheimer J, Brusselle G, Busse W, et al. CAPTAIN study: treatment outcomes from the fluticasone furoate/umeclidinium/vilanterol according to history of severe asthma exacerbations. Presented at: the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting (Virtual Experience); November 13-15, 2020. Abstract P202.