Trial reportTherapeutic advances in respiratory disease
Efficacy of benralizumab in reducing cough and/or dyspnea frequency, and improving cough-specific health-related quality of life in patients with severe eosinophilic asthma in Asia.
Trial report in Therapeutic advances in respiratory disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03186209 (A Multicentre, Randomised, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Efficacy and Safety Study of Benralizumab), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Multicentre, Randomised, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Efficacy and Safety Study of Benralizumab (MEDI-563) Added to Medium to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma.
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11 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundBiologics' efficacy in relieving cough and dyspnea in severe eosinophilic asthma (SEA) is under-characterized.
objectivesThis exploratory analysis evaluated the efficacy of benralizumab separately in reducing cough and/or dyspnea in patients with SEA.
designPost-hoc analysis of a phase III, randomized, double-blind, placebo-controlled trial.
methodsMIRACLE (NCT03186209) data were used, involving patients aged 12-75 years with uncontrolled SEA. Patients reporting baseline frequent cough and/or dyspnea based on St George's Respiratory Questionnaire (SGRQ) items were analyzed. Changes in cough frequency, cough-specific HRQoL, and dyspnea frequency measured through relevant SGRQ items were evaluated over 48 weeks. Subgroup analyses based on baseline blood eosinophil counts (bEOS ⩾300 cells/μL) were conducted.
resultsA total of 383 patients (benralizumab: 189; placebo: 194) with baseline frequent cough and 304 with baseline frequent dyspnea (benralizumab: 151; placebo: 153) were included. The proportions of patients transitioning to non-frequent cough with benralizumab versus placebo were 54.0% versus 39.7% at Week 8 (
conclusionBenralizumab showed potential to rapidly reduce cough and/or dyspnea frequency, and to improve cough-specific HRQoL more quickly than placebo in patients with SEA, with sustained advantage in cough-related SGRQ items through Week 48. Improvements were pronounced in patients with higher baseline bEOS, potentially reflecting a higher disease burden. However, as this was an exploratory analysis, further validation using cough-specific clinical endpoints is warranted.
trial registrationClinicalTrials.gov, NCT03186209, https://clinicaltrials.gov/study/NCT03186209.
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