An Escalating Dose, Randomized, Placebo-controlled, Incomplete-block, 2-period Cross-over Study to Assess the Dose Response for Topical Efficacy Via Airway Responsiveness to Adenosine-5'-Monophosphate (AMP) Challenge and the Dose Response for Systemic Activity Via 24 Hour (h) Plasma Cortisol Suppression and Thereby the Relative Therapeutic Index for Fluticasone Furoate (FF), Fluticasone Propionate (FP) and Budesonide (BUD) in Asthmatic Subjects

Trial Profile

An Escalating Dose, Randomized, Placebo-controlled, Incomplete-block, 2-period Cross-over Study to Assess the Dose Response for Topical Efficacy Via Airway Responsiveness to Adenosine-5'-Monophosphate (AMP) Challenge and the Dose Response for Systemic Activity Via 24 Hour (h) Plasma Cortisol Suppression and Thereby the Relative Therapeutic Index for Fluticasone Furoate (FF), Fluticasone Propionate (FP) and Budesonide (BUD) in Asthmatic Subjects

Recruiting
Phase of Trial: Phase II

Latest Information Update: 20 Oct 2017

At a glance

  • Drugs Budesonide (Primary) ; Fluticasone furoate (Primary) ; Fluticasone propionate (Primary)
  • Indications Asthma
  • Focus Pharmacodynamics; Therapeutic Use
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 18 Sep 2017 Status changed from suspended to recruiting.
    • 29 Aug 2017 Status changed from recruiting to suspended because of pending investigation of a manufacturing issue with the AMP challenge agent .
    • 29 Aug 2017 Planned End Date changed from 15 Dec 2017 to 27 Aug 2018.
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