A Randomised, Multicentre, Double-blind, Placebo-controlled, Crossover Trial Determining the Efficacy of Dry Powder Mannitol in Improving Lung Function in Subjects With Cystic Fibrosis Aged Six to Seventeen Years

Trial Profile

A Randomised, Multicentre, Double-blind, Placebo-controlled, Crossover Trial Determining the Efficacy of Dry Powder Mannitol in Improving Lung Function in Subjects With Cystic Fibrosis Aged Six to Seventeen Years

Completed
Phase of Trial: Phase II

Latest Information Update: 01 Apr 2016

At a glance

  • Drugs Mannitol (Primary)
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Pharmaxis
  • Most Recent Events

    • 16 Dec 2015 Primary endpoint (Effect on lung function (FEV1)) has been met, according to a Pharmaxis media release.
    • 16 Dec 2015 According to a Pharmaxis media release, this trial was designed in consultation with the EMEA as a condition of the marketing authorisation granted for Bronchitol for treating adult cystic fibrosis patients in Europe. Based on the positive trial results Pharmaxis will consider an application to extend the European Union marketing authorisation to include children and adolescents in the indication.
    • 16 Dec 2015 According to a Pharmaxis media release, results from this trial will be presented at the European Cystic Fibrosis Society meeting in June 2016.
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