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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)

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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Apr 2019

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At a glance

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

    • Most Recent Events

    • 26 Mar 2019 Primary endpoint (The annualised rate of clinically significant exacerbations during the Treatment Period.) has not been met.
    • 26 Nov 2018 Results published in the Vectura Media Release
    • 30 Oct 2018 Status changed from active, no longer recruiting to completed.

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