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NCT05573464Recruiting

A Study to Assess the Safety of Budesonide/Glycopyrronium/Formoterol Fumarate With the Hydrofluoroolefin Propellant in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

A Randomized, Double-Blind, 12-Week (With an Extension to 52 Weeks in a Subset of Participants), Multi-Center Study to Assess the Safety of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO Compared to BGF Delivered by MDI HFA in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
AstraZenecaPhase 3ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Chronic Obstructive Pulmonary Disease (COPD)
Drug/Device/Intervention
BGF MDI HFO 320/14.4/9.6 μg
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
AstraZeneca
Location
Phoenix,Newport Beach,Miami,Sarasota,Tampa,Valparaiso,Crowley,North Dartmouth,Saint Louis,Charlotte,Wilmington,Dublin,Grants Pass,Portland,Anderson,Columbia,Gaffney,Longview,McKinney,Richmond,Buenos A, Argentina,Bulgaria,Canada,Germany,Mexico,Poland,Turkey,United Kingdom,United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Sep 27, 2022
End date
Jun 21, 2024
Enrollment
542 participants
Primary outcome

Number (and percentage) of participants with adverse Events - AEs (including SAEs, DAEs, AEOSIs, non-serious AEs),Number (and percentage) of participants with potentially clinically significant changes in Digital 12-lead Holter electrocardiogram (ECG),Number (and percentage) of participants with potentially clinically significant changes in 12-lead ECG,Number (and percentage) of participants with potentially clinically significant changes in laboratory values (hematology, clinical chemistry and urinalysis),Number (and percentage) of participants with potentially clinically significant changes in Blood Pressure,Number (and percentage) of participants with potentially clinically significant changes in pulse rate,Number (and percentage) of participants with potentially clinically significant changes in respiratory rate,Number (and percentage) of participants with potentially clinically significant changes in body temperature

Summary

This is a 12-week (with an extension to 52 weeks in a subset of participants) study comparing
 the safety of BGF MDI HFO twice daily (BID) with BGF MDI HFA BID in participants with
 moderate to very severe COPD.

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
NCT05573464
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05573464 through Pure Global AI's free database. This Phase 3 trial is sponsored by AstraZeneca and is currently Recruiting. The study focuses on Chronic Obstructive Pulmonary Disease (COPD). Target enrollment is 542 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.