A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared With Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to '12 Years With Asthma

Trial Profile

A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared With Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to '12 Years With Asthma

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Apr 2017

At a glance

  • Drugs Budesonide/formoterol (Primary) ; Budesonide
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms CHASE 3
  • Sponsors AstraZeneca
  • Most Recent Events

    • 27 Feb 2017 Results evaluating the efficacy published in the Annals of Allergy, Asthma and Immunology.
    • 30 Jan 2017 According to an AstraZeneca media release, the US Food and Drug Administration (FDA) approved SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol 80/4.5 micrograms for the treatment of asthma in pediatric patients aged six up to 12 years.
    • 11 Nov 2016 The study is part of the CHASE program made up of three pediatric clinical studies conducted to meet Pediatric Research Equity Act (PREA) requirements, fulfill the terms of a Complete Response Letter issued by the US Food and Drug Administration (FDA), and respond to FDA feedback, as per an AstraZeneca media release.
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