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A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-Generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer

NCT06297668 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-08-13

No results posted yet for this study

Summary

This study aims to assess the effect on total systemic exposure and to characterize exposure BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF MDI HFA with a spacer.

Conditions

Interventions

DRUG

Treatment A: BGF MDI HFA

Participants will receive 4 inhalations of BGF MDI HFA as a single dose with AeroChamber Plus Flow-Vu spacer.

DRUG

Treatment B: BGF MDI HFO

Participants will receive 4 inhalations of BGF MDI HFO as a single dose with AeroChamber Plus Flow-Vu spacer.

DRUG

Treatment C: BGF MDI HFO

Participants will receive 4 inhalations of BGF MDI HFO as a single dose without spacer.

DEVICE

AeroChamber Plus Flow-Vu spacer

Participants will receive 4 inhalations of BGF MDI HFA (Treatment A) and BGF MDI HFO (Treatment B) as a single dose with spacer.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2024-06-11
Completion
2024-06-11
FDA Drug
Yes
FDA Device
Yes

Countries

  • Germany

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06297668 on ClinicalTrials.gov