Mepolizumab for the treatment of refractory chronic cough with eosinophilic airways disease (MUCOSA): a randomized, double-blind, placebo-controlled trial

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Background Patients with refractory chronic cough(RCC) with underlying asthma or non-asthmatic eosinophilic bronchitis(NAEB) often have persistent coughing despite inhaled or oral corticosteroid. Eosinophils have been shown to co-localise with sensory airway nerves and are associated with increased neuronal sensitivity. We evaluated whether mepolizumab reduces coughs in RCC with persistent eosinophilic airways disease. Methods A randomized, double-blind, placebo-controlled, parallel-group trial of patients with RCC and sputum eosinophilia ≥2% with either asthma or NAEB was conducted. Patients underwent 1:1 randomization to receive 4 doses of mepolizumab (100mg) or placebo every 4 weeks. The primary endpoint was the change from baseline in 24-hour cough frequency(c/hr) at week 14 using the VitaloJAK cough monitor. Secondary endpoints included change in the Leicester Cough Questionnaire (LCQ) and Cough Severity Visual Analogue Scale(VAS). Results 46 participants were screened and 30 met eligibility (mean age (S.D) 65.8(11.6), 56.7% female, %sputum eosinophils 3.7%(2.4), 19 asthmatics, 11 NAEB). Treatment with mepolizumab did not reduce 24-hour cough frequency compared to placebo at week 14 (18.6% higher, 95% C.I -23% to 82%, P=0.44). There was no difference in LCQ or VAS scores. Mepolizumab showed a significant reduction in sputum and blood eosinophils. Conclusion In this patient population, mepolizumab did not objectively or subjectively improve cough. Targeting eosinophils might not improve cough and an alternate mechanism might be driving cough in this RCC population. Funded by an investigator-initiated grant from GlaxoSmithKline.

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