A 16-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) Treatment in Patients With Moderate to Severe Asthma.

Trial Profile

A 16-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) Treatment in Patients With Moderate to Severe Asthma.

Completed
Phase of Trial: Phase III

Latest Information Update: 18 Aug 2016

At a glance

  • Drugs Reslizumab (Primary)
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms BREATH
  • Sponsors Teva Pharmaceutical Industries
  • Most Recent Events

    • 18 Aug 2016 According to a Teva Pharmaceuticals media release, based on the data from this and other four trials (700193046, 700194103, 700194191 & 700194454) the European Commission has granted marketing authorization for reslizumab for the treatment of asthma.
    • 24 Jun 2016 According to a Teva Pharmaceuticals media release, based on the data from this and other four trials (700193046, 700194103, 700194191 & 700194454) the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization of reslizumab for the treatment of severe eosinophilic asthma. The final decision by the European Commission is expected in the second half of 2016.
    • 24 Mar 2016 Primary endpoint has not been met.(Forced expiratory volume in 1 second at week 16) as per an article published in the Chest
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