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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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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Aug 2024

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At a glance

  • Drugs Benralizumab (Primary)
  • Indications Acute asthma; Asthma
  • Focus Therapeutic Use
  • Acronyms MIRACLE
  • Sponsors AstraZeneca
  • Most Recent Events

    • 20 Aug 2024 According to an AstraZeneca media release, Fasenra (benralizumab) has been approved in China by the National Medical Products Association (NMPA) for the maintenance treatment of severe eosinophilic asthma, based on results from this trial.
    • 29 Aug 2023 According to an AstraZeneca media release, company will present new clinical and real-world data across its leading inhaled, biologic and early science respiratory portfolio at the European Respiratory Society (ERS) International Congress 2023, in Milan, Italy from 9-13 September 2023
    • 07 Feb 2023 Status changed from active, no longer recruiting to completed.

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