The following article is a part of conference coverage from the American College of Allergy, Asthma & Immunology 2020 Annual Scientific Meeting, being held virtually from November 13-15, 2020. The team at Pulmonology Advisor will be reporting on the latest news and research conducted by leading experts in the field. Check back for more from the ACAAI 2020 Annual Scientific Meeting.
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.
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.
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