After careful consideration, the American Academy of Allergy, Asthma & Immunology canceled its annual meeting that was to take place in Philadelphia, Pennsylvania from March 13 to 16, because of concerns regarding the coronavirus disease 2019 (COVID-19) outbreak. Although the live events will not proceed as planned, our readers can still find coverage of research that was scheduled to be presented at the meeting.
Once-daily, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) provided greater increases in lung function compared to once-daily fluticasone furoate/vilanterol in patients with poorly controlled asthma, according to data from a phase 3 clinical trial intended to be presented at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI).
Patients in this randomized, double-blind study (ClinicalTrials.gov Identifier: NCT02924688) had asthma with prebronchodilator FEV1 <85% and an Asthma Control Questionnaire (ACQ-6) score of ≥1.5. Asthma was considered inadequately controlled on inhaled corticosteroids/long-acting β2-agonists. Participants were randomly assigned to either once-daily FF/VI 100/25 µg or 200/25 µg or once-daily FF/UMEC/VI 100/31.25/25 µg, 100/62.5/25 µg, 200/31.25/25 µg, or 200/62.5/25 µg. The analysis was performed in the intent-to-treat population (n=2436).
The primary end point was the mean change from baseline in trough FEV1 at 24 weeks. Secondary end points included annualized rates of moderate/severe asthma exacerbation, safety, as well as the proportion of ACQ-7 and St George’s Respiratory Questionnaire (SGRQ) responders at week 24.
Treatment with FF/UMEC/VI 62.5 µg was associated with a significantly greater improvement in trough FEV1 vs FF/VI with each corresponding dose of FF (100/62.5/25 µg vs FF/VI 100/25 µg, 110 mL [95% CI, 66-153]; 200/62.5/25 µg vs FF/VI 200/25 µg, 92 mL [95% CI, 49-135]; all P <.001). Additionally, treatment with FF/UMEC 31.25 µg/VI was associated with statistically significant improvements in trough FEV1 vs FF/VI (100/31.25/25 µg vs FF/VI 100/25 µg, 96 mL [95% CI, 52-139]; 200/31.25/25 µg vs FF/VI 200/25 µg, 82 mL [95% CI 39-125]).
There was also a numerical reduction the exacerbation rate with FF/UMEC 62.5 µg/VI compared with FF/VI (rate ratio, 0.87; 95% CI, 0.72-1.05). The researchers observed greater ACQ-7 responder rates with FF/UMEC 62.5 µg/VI vs FF/VI (63% vs 55%, respectively; odds ratio [OR], 1.43; 95% CI, 1.16-1.76). Conversely, there were no differences between the 2 treatment regimens in terms of the SGRQ responder rates (69% vs 66%; OR, 1.14; 95% CI, 0.92-1.42). Safety was comparable between FF/UMEC/VI and FF/VI.
Based on these findings, the researchers suggested that dual bronchodilation effects are additive in the treatment of asthma.
Disclosure: This clinical trial was supported by GlaxoSmithKline. Please see the original reference for a full list of authors’ disclosures.
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Pavord I, Peachey G, Kerstjens H, et al. Once-daily, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI in inadequately controlled asthma: the CAPTAIN study. J Allergy Clin Immunol. 2020;145(Suppl 2):AB241.