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Corticosteroid

BGF MDI HFO 320/14.4/9.6μg for Chronic Obstructive Pulmonary Disease

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, 8 and 52 (if attending 56 weeks study)
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares the safety of two inhalers for people with moderate to very severe COPD. One inhaler uses a new type of propellant, while the other uses a traditional one. Both inhalers deliver medicine directly to the lungs to help patients breathe easier. Previous studies have compared the new inhaler with traditional ones.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, 8 and 52 (if attending 56 weeks study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, 8 and 52 (if attending 56 weeks study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number (and percentage) of participants with adverse Events - AEs (including SAEs, DAEs, AEOSIs, non-serious AEs)
Electrocardiogram
Number (and percentage) of participants with potentially clinically significant changes in Blood Pressure
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BGF MDI HFO 320/14.4/9.6μgExperimental Treatment1 Intervention
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFO (HFO-1234ze)
Group II: BGF MDI HFA 320/14.4/9.6 μgActive Control1 Intervention
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) Delivered by MDI HFA
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BGF MDI HFO 320/14.4/9.6 μg
2022
Completed Phase 3
~560

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,403 Previous Clinical Trials
289,124,522 Total Patients Enrolled

Media Library

Budesonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05573464 — Phase 3
Chronic Obstructive Pulmonary Disease Research Study Groups: BGF MDI HFO 320/14.4/9.6μg, BGF MDI HFA 320/14.4/9.6 μg
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Budesonide Highlights & Side Effects. Trial Name: NCT05573464 — Phase 3
Budesonide (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05573464 — Phase 3
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT05573464 — Phase 3
~176 spots leftby Dec 2025