NCT06723756

A Study to Investigate the Exposure of Budesonide, Glycopyrronium, and Formoterol (BGF) Delivered by Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) Compared to a Hydrofluoroalkane (HFA) Propellant MDI in Healthy Adults

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 in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study aims to assess the bioequivalence of the total systemic exposure and safety of budesonide, glycopyrronium, and formoterol (160/14.4/4.8 µg/actuation) when administered as BGF MDI HFO compared with BGF MDI HFA in healthy participants.

Detailed description

This is a Phase I, randomized, double-blind, single-dose, single-site, three way cross-over study to assess the pharmacokinetic (PK) and safety of BGF MDI with HFO propellant compared with BGF MDI with HFA propellant in healthy participants (male or female). The study will comprise of: * A Screening period of up to 27 days; * Three Treatment periods: Participants will receive a single dose of the study intervention on three separate occasions (Period 1, Period 2 and Period 3), with the final dose on Day 2 of Treatment Period 3, and a washout period of 5 to 7 days between administration of each dose; * A final Safety Follow-up within 5 to 7 days after the last administration of the study intervention in Treatment Period 3. Participants will receive all the treatments as a single dose (2 inhalations) (Treatment A \[BGF MDI HFO - test formulation\], and Treatment B \[BGF MDI HFA - reference formulation\]) in one of the 3 possible treatment sequences: ABB, BAB, or BBA. Each participant will be involved in the study for up to 52 days.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Treatment A: BGF MDI HFO	Participants will receive 2 inhalations of BGF MDI HFO (Budesonide/glycopyrronium/fomoterol fumarate pressurized inhalation suspension 160/14.4/4.8 μg per actuation) as a single dose via oral inhalation administered during 1 Treatment period.
DRUG	Treatment B: BGF MDI HFA	Participants will receive 2 inhalations of BGF MDI HFA (Budesonide/glycopyrronium/fomoterol fumarate pressurized inhalation suspension 160/14.4/4.8 μg per actuation) as a single dose via oral inhalation administered during 2 Treatment periods.

Timeline

• Start date: 2025-01-23
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-12-09
• Last updated: 2025-06-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study