BGF MDI 320/28.8/9.6 μg for Asthma
Phase-Based Progress Estimates
Effectiveness
Safety
Asthma
BGF MDI 320/28.8/9.6 μg - DrugEligibility
Any Age
All Sexes
What conditions do you have?
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Eligibility
Any Age
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing an inhaler to see if it can help people with severe asthma who aren't responding to other treatments.
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 9 Secondary · Reporting Duration: Up to 52 Weeks
24 Weeks
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24
Change from baseline in morning pre-dose trough FEV1 at Week 24
Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24
Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (≥0.5 decrease equals response) at Week 24
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) (≥0.5 increase equals response) at Week 24
Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 unit decrease equals response) at Week 24
Day 1
Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1
Up to 52 Weeks
Rate of moderate/severe asthma exacerbations
Rate of severe asthma exacerbations
Time to first moderate/severe asthma exacerbation
Time to first severe asthma exacerbation
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
4 Treatment Groups
Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg
1 of 4
Symbicort®
1 of 4
Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg
1 of 4
BGF MDI 320/14.4/9.6 μg
1 of 4
Active Control
Experimental Treatment
2200 Total Participants · 4 Treatment Groups
Primary Treatment: BGF MDI 320/28.8/9.6 μg · No Placebo Group · Phase 3
Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg
Drug
Experimental Group · 1 Intervention: BGF MDI 320/28.8/9.6 μg · Intervention Types: DrugBGF MDI 320/14.4/9.6 μg
Drug
Experimental Group · 1 Intervention: BGF MDI 320/14.4/9.6 μg · Intervention Types: DrugBudesonide and formoterol fumarate (BFF) MDI 320/9.6 μg
Drug
ActiveComparator Group · 1 Intervention: BFF MDI 320/9.6 μg · Intervention Types: DrugSymbicort®
Drug
ActiveComparator Group · 1 Intervention: BFF pMDI 320/9 μg · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BGF MDI 320/14.4/9.6 μg
2015
Completed Phase 3
~11120
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 52 weeks
Who is running the clinical trial?
AstraZenecaLead Sponsor
3,956 Previous Clinical Trials
91,806,661 Total Patients Enrolled
307 Trials studying Asthma
694,658 Patients Enrolled for Asthma
Robert Wise, MDPrincipal InvestigatorJohns Hopkins University
7 Previous Clinical Trials
7,470 Total Patients Enrolled
3 Trials studying Asthma
381 Patients Enrolled for Asthma
Eligibility Criteria
Age Any Age · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a negative result if you are 12 to <18 years of age.
You have a minimum FEV1 post-albuterol of at least 200 mL
Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3.\n
Note: Reversibility testing is still required at Visit 2 and/or Visit 3, even if the patient has documented historical reversibility reported in the 12 months prior to Visit 1.
You are aged between 12 and 80 years, male or female, BMI <40 kg/m2, and you have no medical history of breast cancer.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Texas | 44.4% |
| New York | 33.3% |
| Pennsylvania | 11.1% |
| Other | 11.1% |
How old are they?
| 18 - 65 | 87.5% |
| < 18 | 12.5% |
What site did they apply to?
| Research Site | 40.0% |
| Other | 60.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 87.5% |
| Did not meet criteria | 12.5% |
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