CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 108 enrolled
Drug / intervention
Treatment A (BGF MDI HFO with oral activated charcoal) +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/NCT05477108
NCT05477108Phase 1Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Jul 28, 2022·Updated Aug 28, 2025

In Brief

A Phase 1 clinical trial evaluating Treatment A (BGF MDI HFO with oral activated charcoal) and Treatment B (BGF MDI HFA with oral activated charcoal) for Chronic Obstructive Pulmonary Disease. Completed, enrolled 108 participants across 1 site.

Detailed Summary

The study will assess the Pharmacokinetic (PK) and safety of BGF MDI \[Budesonide/glycopyrronium/formoterol (BGF) metered dose inhaler (MDI)\] formulated with 2 different propellants :Hydrofluoroolefin (HFO) and Hydrofluoroalkane (HFA) with oral activated charcoal in healthy subjects (male or female).

Study Details

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

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJul 28, 2022
Enrollment StartJul 29, 2022
Primary CompletionApr 11, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.9 years ago

Interventions

Treatment A (BGF MDI HFO with oral activated charcoal)drug

Subject will receive 4 inhalations as a single dose with oral activated charcoal - test formulation; administered during 1 Treatment Period.

Treatment B (BGF MDI HFA with oral activated charcoal)drug

Subject will received 4 inhalations as a single dose with oral activated charcoal - reference formulation; administered during 2 Treatment Periods.