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A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3 Efficacy and Safety Study of Benralizumab (MEDI-563) to Reduce Oral Corticosteroid Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy

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Trial Profile

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3 Efficacy and Safety Study of Benralizumab (MEDI-563) to Reduce Oral Corticosteroid Use in Patients With Uncontrolled Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jul 2023

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At a glance

  • Drugs Benralizumab (Primary)
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms ZONDA
  • Sponsors AstraZeneca

    • Most Recent Events

    • 24 May 2023 Results of an analysis assessing rates of clinical remission after treatment with benralizumab in patients with SEA with or without CRSwNP from 5 clinical studies (SIROCCO, CALIMA, ZONDA, ANDHI and PONENTE) presented at the 119th International Conference of the American Thoracic Society
    • 14 Mar 2022 Results of post-hoc pooled analysis assessing composite remission definition to characterize individual responses to benralizumab after 6 and 12 months in 3 phase III studies (SIROCCO (NCT01928771); CALIMA (NCT01914757); ZONDA (NCT02075255)) were published in the Advances in Therapy.
    • 21 Oct 2020 Results of post-hoc analysis assessing fficacy of benralizumab in reducing AER for patients with and without early clinically meaningful improvements above baseline in pre-bronchodilator FEV1, presented at the CHEST Annual Meeting 2020 by Annual Meeting of the American College of Chest Physicians.
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