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)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Sep 2017

At a glance

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

    • 06 Sep 2017 Planned End Date changed from 1 Dec 2016 to 31 Dec 2018, as reported in a Vectura media release
    • 06 Sep 2017 According to a Vectura media release, this study is expected to complete in H2 2018.
    • 06 Sep 2017 Status changed from recruiting to active, no longer recruiting, as reported in a Vectura media release
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