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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Dec 2022

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At a glance

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

    • 14 Nov 2022 Results of post hoc analysis examined data from the IA05 (NCT00079937) and PROSPERO (NCT01922037), presented at the 2022 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology
    • 08 Nov 2021 Results of post-hoc sub-group analysis was presented at the 2021 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology.
    • 25 Feb 2019 Results of post-hoc analysis assessing blood eosinophil levels data from three phase III studies including this study at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
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