The efficacy and safety of Fluticasone Furoate/Umeclidinium/vilanterol (FF/UMEC/VI) on cough symptoms in adult patients with asthma, a randomized double-blind, placebo-controlled, parallel group study: Chronic Cough in Asthma (COCOA) study.

Background: Persistent cough bothers many patients with asthma because it worsens their quality of life; therefore, it must be remedied immediately. The efficacy of triple therapy as a first-line treatment for cough remains unclear. To evaluate the effectiveness and safety of the triple therapy against persistent cough, the clinical effect of regular treatment with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or placebo in adult patients with asthma was investigated.

Methods: This randomized, double-blind, placebo-controlled, parallel-group multicenter trial recruited asthma patients with persistent cough from hospitals and primary care clinics between June 2022 and December 2023. Participants were randomly given FF/UMEC/VI 200/62.5/25 µg or placebo for 6 wk. The primary endpoint was the average change in the cough symptom score from baseline to week 6. Secondary outcomes were effectiveness on cough-related disease burdens (asthma control questionnaire [ACQ]-5, Leicester cough questionnaire [LCQ] and nighttime awakening). Furthermore, lung function and adverse events were evaluated.

Results: The decrease from baseline in the cough symptom score at week 6 was significantly greater in the FF/UMEC/VI group than in the placebo group (p = 0.006). The ACQ-5 scores showed a greater decrease in the FF/UMEC/VI group than in the placebo group. The change from baseline in morning and evening FEV₁ increased in the FF/UMEC/VI group as with the results of peak expiratory flow. No significant adverse events associated with FF/UMEC/VI were noted.

Conclusions: In asthma patients with persistent cough, FF/UMEC/VI showed an early response and a significant effect on cough and lung function for 6 wk of treatment.

This study is registered with jRCTs031210412.