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A Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort Inhalation Aerosol in Healthy Volunteers

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Trial Profile

A Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort Inhalation Aerosol in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 May 2020

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At a glance

  • Drugs Budesonide/formoterol/glycopyrrolate (Primary) ; Budesonide/formoterol; Formoterol/glycopyrrolate
  • Indications Asthma; Chronic obstructive pulmonary disease
  • Focus Adverse reactions
  • Sponsors Pearl Therapeutics

    • Most Recent Events

    • 21 Mar 2020 Results of pooled analysis of four studies (NCT01980615, NCT02189304, NCT03075267, NCT02197975) presented at the 121st Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 24 Dec 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 05 Dec 2013 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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