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Bronchodilator

BGF with Different Propellants for COPD

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be 40 to 80 years inclusive at the time of signing the ICF

Current or former smokers with a history of at least 10 pack-years of tobacco smoking

Must not have

Diagnosis of narrow-angle glaucoma or symptomatic prostatic hypertrophy

History of QT prolongation associated with another medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 16 weeks and per treatment group per 4 weeks treatment period

Awards & highlights

Pivotal Trial

Summary

This trial will measure how well different forms of orally inhaled BGF treatment work for people with COPD over a period of 15-16 weeks. Participants will have regular in-clinic visits and use rescue SABA during the study.

Who is the study for?

This trial is for adults aged 40-80 with COPD who have smoked at least the equivalent of 10 pack-years. They must be able to perform proper inhaler and breathing test techniques, have a certain blood cell count and lung function level, and either not be able to bear children or use effective birth control. People can't join if they've had asthma, recent drug/alcohol abuse, certain heart conditions, other respiratory disorders, or are pregnant.

What is being tested?

The study tests whether BGF medication using a new propellant (HFO) works as well as the approved version with an older propellant (HFA) in improving lung function for COPD patients. Participants will try both versions and a placebo during different periods over about 15-16 weeks while attending regular clinic visits.

What are the potential side effects?

Possible side effects include typical reactions to inhaled medications like throat irritation or dry mouth; however specific side effects related to BGF MDI HFO versus BGF MDI HFA haven't been provided but may align with common COPD treatment reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 80 years old.

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I have smoked at least 10 packs of cigarettes a year.

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I have been diagnosed with COPD by a doctor.

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I am not able to have children or I use effective birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with narrow-angle glaucoma or have problems due to an enlarged prostate.

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I have had a heart rhythm issue with another medication.

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I haven't used herbal products in the last 2 weeks or am willing to stop during the study.

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I will be staying in the hospital during the study.

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I am a woman not planning to become pregnant and I use effective birth control.

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I have been diagnosed with asthma.

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My cancer cannot be removed with surgery and was diagnosed within the last 5 years.

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I have sleep apnea that is not well-managed.

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My COPD is caused by α1-antitrypsin deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 16 weeks and per treatment group per 4 weeks treatment period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over 16 weeks and per treatment group per 4 weeks treatment period

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 16 weeks and per treatment group per 4 weeks treatment period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Other study objectives

Change in morning pre-dose trough FEV1

Changes in FEV1 AUC (0-4)

Number (and percentage) of participants with adverse Events

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Treatment Sequence 6Experimental Treatment3 Interventions

Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions in the following sequence. Sequence 6: Placebo MDI HFA BGF MDI HFA 320/14.4/9.6 μg BGF MDI HFO 320/14.4/9.6 μg

Group II: Treatment Sequence 5Experimental Treatment3 Interventions

Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 5: Placebo MDI HFA BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg

Group III: Treatment Sequence 4Experimental Treatment3 Interventions

Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 4: BGF MDI HFA 320/14.4/9.6 μg Placebo MDI HFA BGF MDI HFO 320/14.4/9.6 μg

Group IV: Treatment Sequence 3Experimental Treatment3 Interventions

Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 3: BGF MDI HFA 320/14.4/9.6 μg BGF MDI HFO 320/14.4/9.6 μg Placebo MDI HFA

Group V: Treatment Sequence 2Experimental Treatment3 Interventions

Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 2: BGF MDI HFO 320/14.4/9.6 μg Placebo MDI HFA BGF MDI HFA 320/14.4/9.6 μg

Group VI: Treatment Sequence 1Experimental Treatment3 Interventions

Each participant will participate in 3 treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) in the following sequence. Sequence 1: BGF MDI HFO 320/14.4/9.6 μg BGF MDI HFA 320/14.4/9.6 μg Placebo MDI HFA

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BGF MDI HFA 320/14.4/9.6 μg

2022

Completed Phase 3

~560

0 / 13Eligibility criteria met