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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Feb 2018

At a glance

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

    • 26 Feb 2018 According to an AstraZeneca media release, health Canada has approved Fasenra (benralizumab injection) as an add-on maintenance treatment for adult patients with severe eosinophilic asthma, based on results from the WINDWARD clinical program.
    • 19 Jan 2018 According to an AstraZeneca media release, the Japanese Ministry of Health, Labour and Welfare has approved Fasenra (benralizumab) as an add-on treatment for bronchial asthma in patients who continue to experience asthma exacerbations despite treatment with high-dose inhaled corticosteroid and other asthma controllers. The approval is based on the results from the WINDWARD programme, including the SIROCCO, CALIMA and ZONDA trials.
    • 10 Jan 2018 According to an AstraZeneca media release, based on the results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III OCS-sparing trial, ZONDA, the European Commission (EC) has approved Fasenra (benralizumab) as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists.
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