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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4, 8 and 52 (if attending 56 weeks study)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, 8 and 52 (if attending 56 weeks study)
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 moreAwards & 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
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,388 Previous Clinical Trials
289,109,215 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been using specific types of inhalers to manage your COPD for at least 6 weeks before the study.You are able to change your current medication for chronic obstructive pulmonary disease (COPD) as needed for the study.You must be between 40 and 80 years old when you agree to participate in the study.Your lung function test results show that your FEV1 is lower than 80% of what is expected for someone of your age and size.You have been using herbal products through inhalation or nebulizer in the past two weeks and are unwilling to stop using them during the study.You require oxygen therapy for an extended period of time.You must be willing to stay at the study center for the required amount of time to complete all necessary check-ups.You need to be able to use an inhaler and perform a breathing test correctly.You have smoked for at least 10 years, averaging one pack of cigarettes per day.You have or had a serious health condition that could affect the study results.You have had COVID-19 or were hospitalized for it within 8 weeks before the study starts or during the screening period.You have cancer that cannot be removed by surgery and has not been completely gone for at least 5 years before the start of the study.You have a history of drug or alcohol abuse within the last year.You have a known allergy to beta2-agonists, muscarinic antagonists, or corticosteroids, or any part of the inhaler.You have smoked for at least 10 years in total.You have sleep apnea that cannot be managed.You recently had a moderate or severe COPD exacerbation or respiratory infection within the past 4 weeks before the start of the study.You have a lung condition with a specific measurement of lung function that falls below a certain level.You have a high level of anxiety at the first visit based on a CAT score of 10 or higher.You have been diagnosed with COPD by a doctor according to established medical guidelines.You have narrow angle glaucoma that is not being properly treated, or you have experienced a recent change in vision that may impact the study.You have other respiratory conditions such as tuberculosis, lung cancer, cystic fibrosis, or other serious lung diseases.You have severe COPD that is life-threatening in the near future.
Research Study Groups:
This trial has the following groups:- Group 1: BGF MDI HFO 320/14.4/9.6μg
- Group 2: BGF MDI HFA 320/14.4/9.6 μg
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT05573464 — Phase 3
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