A 1 Year, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Evaluation of Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Persistent, Inadequately Controlled Allergic Asthma

Trial Profile

A 1 Year, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Evaluation of Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Persistent, Inadequately Controlled Allergic Asthma

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Mar 2017

At a glance

  • Drugs Omalizumab (Primary) ; Fluticasone propionate
  • Indications Allergic asthma
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 06 Mar 2017 Results of posthoc analysis assessing reductions in asthma exacerbations based on subgroups stratified by blood eosinophils, presented at the 2017 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
    • 07 Jul 2016 Results published in a Genentech media release.
    • 07 Jul 2016 According to a Genentech media release, t0he US FDA has approved omalizumab (Xolair) for the treatment of moderate to severe persistent asthma in children six to 11 years of age. The approval was supported from by data from this and other phase III trials.
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