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A Phase I, Randomized, Double-blind, Single-dose, Partial Replicate, 3-way Cross-over Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA

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A Phase I, Randomized, Double-blind, Single-dose, Partial Replicate, 3-way Cross-over Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 25 Jun 2024

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At a glance

  • Drugs Budesonide/formoterol/glycopyrrolate (Primary) ; Charcoal (Primary)
  • Indications Chronic obstructive pulmonary disease
  • Focus Pharmacokinetics
  • Sponsors AstraZeneca

    • Most Recent Events

    • 22 May 2024 Results assessing lung exposure bioequivalence for each component of BGF via pMDI using the low GWP propellant hydrofluoroolefin-1234ze (HFO-1234ze) versus HFA-134a with oral activated charcoal, presented at the 120th International Conference of the American Thoracic Society.
    • 09 May 2023 Status changed from recruiting to completed.
    • 23 Feb 2023 Planned End Date changed from 23 Mar 2023 to 10 Apr 2023.

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