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
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History