CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 108 enrolled
Drug / intervention
Treatment A: BGF MDI HFO +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05569421
NCT05569421Phase 1Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Oct 6, 2022·Updated Aug 22, 2025

In Brief

A Phase 1 clinical trial evaluating Treatment A: BGF MDI HFO and Treatment B: BGF MDI HFA for Chronic Obstructive Pulmonary Disease. Completed, enrolled 108 participants across 1 site.

Detailed Summary

The study will evaluate bioequivalence, pharmacokinetics, safety, and tolerability of Budesonide, Glycopyrronium and Formoterol (BGF) metered dose inhaler (MDI) formulated with hydrofluoroolefin (HFO) \[Test\] and hydrofluoroalkane (HFA) \[Reference\] in healthy participants (male or female).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesUnited States
CollaboratorsParexel

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedOct 6, 2022
Enrollment StartOct 11, 2022
Primary CompletionApr 14, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.7 years ago

Interventions

Treatment A: BGF MDI HFOdrug

Participants will receive 4 oral inhalations as a single dose - test formulation; administered during 1 treatment period.

Treatment B: BGF MDI HFAdrug

Participants will receive 4 oral inhalations as a single dose - reference formulation; administered during 2 treatment periods.