A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two doses of nebulised budesonide delivered by the VR475 Inhalation System, with an open-label comparison to conventionally nebulised budesonide, in patients with uncontrolled asthma despite treatment with high dose inhaled corticosteroid and at least a second controller (GINA Step 4) and those receiving oral corticosteroid (GINA Step 5)

Trial Profile

A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two doses of nebulised budesonide delivered by the VR475 Inhalation System, with an open-label comparison to conventionally nebulised budesonide, in patients with uncontrolled asthma despite treatment with high dose inhaled corticosteroid and at least a second controller (GINA Step 4) and those receiving oral corticosteroid (GINA Step 5)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 May 2017

At a glance

  • Drugs Budesonide (Primary)
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Sponsors Vectura
  • Most Recent Events

    • 22 Dec 2016 Planned number of patients changed from 474 to 600.
    • 22 Nov 2016 According to a Vectura Group plc media release, over 450 patients have been enrolled in this trial.
    • 26 May 2016 Results are anticipated in mid-2018, as per Vectura media release.
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