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NCT06297668Not yet recruiting

A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) Hydrofluoroolefin (HFO) With a Spacer (Treatment B), BGF MDI Hydrofluoroalkane (HFA) With a Spacer (Treatment A), as Well as BGF MDI HFO Without a Spacer (Treatment C).

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
AstraZenecaPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Chronic Obstructive Pulmonary Disease
Drug/Device/Intervention
Treatment A: BGF MDI HFA
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AstraZeneca
Location
Berlin,Harrow, Germany,United Kingdom
Timeline & enrollment
Phase
Phase 1
Start date
Apr 26, 2024
End date
Jun 13, 2024
Enrollment
42 participants
Primary outcome

Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI,Maximum Observed Concentration (Cmax) of BGF MDI

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.

ICD-10 classifications
Other chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease, unspecifiedOther specified chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease with acute exacerbation, unspecifiedChronic obstructive pulmonary disease with acute lower respiratory infection
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06297668
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06297668 through Pure Global AI's free database. This Phase 1 trial is sponsored by AstraZeneca and is currently Not yet recruiting. The study focuses on Chronic Obstructive Pulmonary Disease. Target enrollment is 42 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.