The addition of umeclidinium (UMEC) to fluticasone furoate/vilanterol (FF/VI) improved lung function and symptom control in patients with uncontrolled asthma, regardless of cardiovascular (CV) risk, according to the results of the CAPTAIN study (ClinicalTrials.gov Identifier: NCT02924688), presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting, held February 26 to March 1, 2021.

The trial was a randomized, double-blind, 24- to 52-week, parallel-group study of adults with uncontrolled asthma (prebronchodilator forced expiratory volume in 1 second [FEV1] ≥30%, <85% predicted; Asthma Control Questionnaire [ACQ]-6 score ≥1.5). Researchers examined the outcomes in subgroups defined by CV risk. A change in baseline low concentration FEV1 at Week 24 and annualized rate of moderate to severe exacerbations were evaluated in stable patients either with or without CV risk at screening for FF/UMEC/VI 100/62.5/25 mcg (n=198/208) vs FF/VI 100/25 mcg (n=206/201), and FF/UMEC/VI 200/62.5/25 mcg (n=204/204), vs FF/VI 200/25 mcg (n=205/201).

Of the 2436 participants in the intent-to-treat population, nearly half (48%) had CV risk. Similar improvements in baseline FEV1 were observed in patients with or without CV risk, respectively, with FF/UMEC/VI 100/62.5/25 mcg vs FF/VI 100/25 mcg (108 mL [95% CI, 46-169]; 112 mL [95% CI, 51-173]), and with FF/UMEC/VI 200/62.5/25 mcg vs FF/VI 200/25 mcg (81 mL [95% CI, 20-142] 103 mL [95% CI, 42-164]).

Within the overall population, exacerbation rates were lower in both subgroups when UMEC was added to FF/VI 100/25 mcg, although there was no definitive pattern of response in subgroups when UMEC was added to FF/VI 200/25 mcg. Safety profiles were similar across subgroups.


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In conclusion, lung function improved after UMEC was added to FF/VI, regardless of cardiovascular risk, but the effects on moderate to severe exacerbation rates were less consistent.

Disclosure: This clinical trial was supported by GlaxoSmithKline. Please see the original reference for a full list of authors’ disclosures.

Reference

Hanania N, Bailes Z, Chang S, et al. CAPTAIN: effects of cardiovascular risk on response to triple therapy in patients with inadequately controlled asthma on inhaled corticosteroids/long-acting β2-agonists (ICS/LABA). Presented at: the American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting; February 26-March 1, 2021. Abstract 179. 

This article originally appeared on Pulmonology Advisor