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BFF MDI 160/9.6 μg BID (320/19.2μg/day) for Asthma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Research Site, Huntington Beach, CAAsthmaBFF MDI 160/9.6 μg BID (320/19.2μg/day) - Drug
Eligibility
12 - 80
All Sexes
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Study Summary

This trial tests if two inhalers are better than one to control asthma in adults & teens.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

2
Treatment A (PT027) [experimental], then Treatment B (PT007) [active comparator] Part 1 & 2
2
BGF MDI 320/28.8/9.6 μg
2
Tezepelumab

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: at Week 12

at Week 12
Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) at Week 12
Percentage of responders in ACQ-7 (≥ 0.5 decrease equals response) at Week 12
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s) +12) (≥ 0.5 increase equals response) at Week 12
at week 12
US (Key secondary): Change from baseline in morning pre-dose trough FEV1 at Week 12
United States (US): Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 12
on Day 1
Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1
over 12 Weeks
Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 12 Weeks

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

3
Treatment A (PT027) [experimental], then Treatment B (PT007) [active comparator] Part 1 & 2
3
BGF MDI 320/28.8/9.6 μg
3
Tezepelumab

Trial Design

2 Treatment Groups

BD MDI 160 μg BID (320 μg/day)
1 of 2
BFF MDI 160/9.6 μg BID (320/19.2μg/day)
1 of 2

Active Control

Experimental Treatment

340 Total Participants · 2 Treatment Groups

Primary Treatment: BFF MDI 160/9.6 μg BID (320/19.2μg/day) · No Placebo Group · Phase 3

BFF MDI 160/9.6 μg BID (320/19.2μg/day)
Drug
Experimental Group · 1 Intervention: BFF MDI 160/9.6 μg BID (320/19.2μg/day) · Intervention Types: Drug
BD MDI 160 μg BID (320 μg/day)
Drug
ActiveComparator Group · 1 Intervention: BD MDI 160 μg BID (320 μg/day) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at week 12

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,021 Previous Clinical Trials
240,380,785 Total Patients Enrolled
312 Trials studying Asthma
618,052 Patients Enrolled for Asthma

Eligibility Criteria

Age 12 - 80 · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an ACQ-7 total score of 1.5 or higher at Visits 1 and 4.
You are between 12 and 80 years old, male or female, with a body-mass index below 40 kilograms per square metre; any females of childbearing potential should be using effective contraception.
You have had stable asthma based on the investigator's assessment and symptom worsening evaluation.
You can demonstrate a satisfactory method for administering MDI.
You must have had physician-diagnosed asthma for at least 6 months prior to Visit 1 and adolescents aged 12 - < 18 years are required to provide healthcare records from the past year in order to confirm eligibility.
You have a pre-bronchodilator/pre-dose FEV1 of less than 90% predicted normal value at Visits 1, 2, and 3 and an FEV1 between 50%-90% at Visit 4 (before randomization).
You must demonstrate a post-albuterol increase in FEV1 of at least 12% and 200 mL if you are 18 years old or older, or a post-albuterol increase in FEV1 by 12%, regardless of age, to be eligible for this study.
The pre-bronchodilator/pre-dose FEV1 at Visits 2, 3 and 4 must not differ more than 20% from the preceding visit.
You are willing and capable, as judged by the Investigator, to adjust your current asthma treatment according to study requirements.
You have completed the daily eDiary and verifiably taken two puffs of run-in BD MDI for 10 mornings and 10 evenings in the last 14 days prior to randomization with at least 70% compliance.
You have been consistently utilizing an ICS or combined ICS/LABA medication regimen with permitted doses for a minimum of 8 weeks preceding Visit 1.

Who else is applying?

What state do they live in?
California100.0%
What site did they apply to?
Research Site100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
How many prior treatments have patients received?
3+100.0%
References

Frequently Asked Questions

Does this research endeavor allow participants aged 40 or above to join?

"The criteria for inclusion in this trial necessitates that enrollees are between the ages of 12 and 80. There are 128 trials specifically targeting minors, whereas 204 studies cater to those above the age of 65." - Anonymous Online Contributor

Unverified Answer

Is my profile compatible with the requirements of this clinical trial?

"Eligible candidates for this medical trial must be between the ages of 12 and 80, suffer from asthma and are expected to number around 340 people." - Anonymous Online Contributor

Unverified Answer

How many venues is this clinical experiment being conducted in?

"This trial is currently operational in 44 clinical locations, including Los Angeles, Newport Beach and San Diego. Patients should pick the closest site to their home so they can reduce travel commitments if they join this study." - Anonymous Online Contributor

Unverified Answer

What potential risks come with utilizing the BFF MDI 160/9.6 μg BID (320/19.2μg/day) treatment protocol?

"There is a high degree of trust regarding the safety profile of BFF MDI 160/9.6 μg BID (320/19.2μg/day) given that it is currently in Phase 3 trials, which means there has been ample evidence to support its efficacy and security protocols have been rigorously tested throughout multiple rounds of testing." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies left for participants in this examination?

"This investigation, which was initially posted on February 24th 2023 and last modified the day prior, is not open to recruitment at this time. However, there are 330 other trials actively recruiting participants as of now." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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