Effects of Cardiovascular Risk in Response to Triple Therapy in Asthma

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.

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.