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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time to onset defined as the first post-dose timepoint where the mean change from baseline in fev1 exceeds 100 ml on tp 1 day 1
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time to onset defined as the first post-dose timepoint where the mean change from baseline in fev1 exceeds 100 ml on tp 1 day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and time to onset defined as the first post-dose timepoint where the mean change from baseline in fev1 exceeds 100 ml on tp 1 day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Other outcome measures
Change in morning pre-dose trough FEV1
Changes in FEV1 AUC (0-4)
Mean change in FEV1
+3 more

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

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,272 Previous Clinical Trials
288,612,435 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include participants aged sixty and above?

"The requirements for entry to this medical trial is a patient age of between 40 and 80 years. On the other hand, there are 37 trials available that accept participants under 18 years old, as well as 500 studies open to those over 65."

Answered by AI

What can be said about the safety of Treatment Sequence 1 for individuals?

"The safety of Treatment Sequence 1 received a score of 3 because there is ample evidence from Phase 3 trials to suggest its efficacy and safety."

Answered by AI

Is it possible to volunteer for this research endeavor?

"This experiment is on the lookout for 240 individuals, aged 40 to 80, who suffer from chronic obstructive pulmonary disorder. Noteworthy requirements include having a history of smoking at least 10 pack-years and being competent with inhaler delivery systems and pulmonic testing procedures."

Answered by AI

Are there any vacancies remaining for prospective participants in this trial?

"As disclosed on clinicaltrials.gov, this study is not currently accepting applicants. This particular medical trial first appeared on the 15th of January 2024 and was most recently updated October 4th 2023. Despite its inactive status, there are 521 additional trials actively recruiting participants at present."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a New Propellant (HFO) in Participants 40 to 80 Years of Age With COPD
2024. "A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a New Propellant (HFO) in Participants 40 to 80 Years of Age With COPD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06075095.
All > Vancouver
~160 spots leftby Sep 2025
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