Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT06297668
Status:
COMPLETED
Last Update Posted:
2025-08-13
First Post:
2024-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase I, Randomized, Partial Double-blind, Single-dose, 3-Way Cross-over Study to Assess the Total Systemic Exposure of Budesonide, Glycopyrronium, and Formoterol for BGF MDI HFO Compared With BGF MDI HFA Using an AeroChamber Plus Flow-Vu Spacer and to Compare the Total Systemic Exposure of BGF MDI HFO With a Spacer to BGF MDI HFO Without a Spacer
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
This is a Phase I, randomized, partial double-blind, single dose, three way cross-over study to assess the effect of total systemic exposure of BGF when administered as BGF MDI HFO compared with BGF MDI HFA Using an AeroChamber Plus Flow-Vu Spacer and to compare the Total Systemic Exposure of BGF MDI HFO with a Spacer to BGF MDI HFO without a Spacer in healthy participants (male or female).
The study will comprise of:
* A Screening Period of up to 27 days prior to first dosing.
* Three treatment periods: participants will be resident at the Clinical Unit from Day -1 until 24 hours after dosing with the final treatment, with a washout period of 3 to 7 days between each dose administration.
* Follow-up: a final Follow-up Phone Call within 5 to 7 days after the last administration of BGF MDI in Treatment Period 3.
Participants will receive all 3 treatments as a single dose (4 inhalations) (Treatment A \[BGF MDI HFA with AeroChamber Plus Flow-Vu spacer - reference formulation\], Treatment B \[BGF MDI HFO with AeroChamber Plus Flow-Vu spacer - test formulation\], and Treatment C \[BGF MDI HFO without spacer\]) (1 treatment per treatment period) in one of 6 possible treatment sequences; ABC, ACB, BAC, BCA, CAB, or CBA.
The study will comprise of:
* A Screening Period of up to 27 days prior to first dosing.
* Three treatment periods: participants will be resident at the Clinical Unit from Day -1 until 24 hours after dosing with the final treatment, with a washout period of 3 to 7 days between each dose administration.
* Follow-up: a final Follow-up Phone Call within 5 to 7 days after the last administration of BGF MDI in Treatment Period 3.
Participants will receive all 3 treatments as a single dose (4 inhalations) (Treatment A \[BGF MDI HFA with AeroChamber Plus Flow-Vu spacer - reference formulation\], Treatment B \[BGF MDI HFO with AeroChamber Plus Flow-Vu spacer - test formulation\], and Treatment C \[BGF MDI HFO without spacer\]) (1 treatment per treatment period) in one of 6 possible treatment sequences; ABC, ACB, BAC, BCA, CAB, or CBA.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-504089-43-00 | REGISTRY | CTIS | View |