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Bronchodilator
BDA MDI vs. AS MDI for Asthma
Phase 3
Waitlist Available
Research Sponsored by Bond Avillion 2 Development LP
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of asthma by a prescribing healthcare professional. Protocol-specified documentation of asthma diagnosis is required to confirm diagnosis of asthma.
Participants actively using SABA alone or SABA on a background of either low-dose ICS or LTRA.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening (day -28 to 0) to end of the study or early study discontinuation (upto week 52)
Awards & highlights
Study Summary
This trial found that BDA MDI was more effective than AS MDI in reducing exacerbations and improving asthma control.
Who is the study for?
This trial is for asthma patients aged 12 or older who use short-acting beta agonists (SABA) at least twice in the past two weeks, with or without low-dose inhaler steroids or leukotriene receptor antagonists (LTRA). They must not be pregnant, breastfeeding, using certain other asthma medications regularly, hospitalized for asthma recently, treated with biologics for asthma ever, or have significant lung diseases besides asthma.Check my eligibility
What is being tested?
The study compares Budesonide/Albuterol Sulfate metered dose inhaler (BDA MDI) versus Albuterol Sulfate metered dose inhaler (AS MDI), both used as needed by participants. The goal is to assess which treatment is more effective and safer over a period of up to 12 months when taken during an asthma attack.See study design
What are the potential side effects?
Potential side effects may include throat irritation, headache, rapid heartbeat, nervousness and muscle cramps. Rarely there might be allergic reactions like rash or worsening breathing problems immediately after use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with asthma by a doctor.
Select...
I use a quick-relief inhaler, with or without long-term asthma control medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening (day -28 to 0) to end of the study or early study discontinuation (upto week 52)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening (day -28 to 0) to end of the study or early study discontinuation (upto week 52)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Annualized rate of severe asthma exacerbations (≥12 years)
Annualized rate of severe asthma exacerbations (≥18 years)
Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
+7 moreSide effects data
From 2018 Phase 2 trial • 46 Patients • NCT033714597%
Feeling Jittery
4%
Tremor
4%
Headache
2%
Vomiting
2%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
AS MDI
Proventil
Trial Design
2Treatment groups
Experimental Treatment
Group I: PT027Experimental Treatment1 Intervention
Participants will receive Budesonide and Albuterol Sulfate Pressurised Inhalation Suspension 160/180 μg up to a maximum of 12 inhalations to max dose.
Group II: PT007Experimental Treatment1 Intervention
Participants will receive Albuterol Sulfate Pressurised Inhalation Suspension 180 μg up to a maximum of 12 inhalations to max dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AS MDI
2017
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
Bond Avillion 2 Development LPLead Sponsor
5 Previous Clinical Trials
4,518 Total Patients Enrolled
3 Trials studying Asthma
4,145 Patients Enrolled for Asthma
ParexelIndustry Sponsor
303 Previous Clinical Trials
98,308 Total Patients Enrolled
20 Trials studying Asthma
37,577 Patients Enrolled for Asthma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken medication for asthma before.I am unwilling to stop using my home supply of oral corticosteroids for asthma during the study.Your asthma condition is rated 2 or higher on the Asthma Impairment and Risk Questionnaire during screening and randomization.I am a man in a heterosexual relationship using effective birth control or am surgically sterile.I am 12 years or older and can sign the consent form, or my guardian will if I'm under the age of majority.I have been using asthma medication regularly for the last 3 months.Your score on the Asthma Impairment and Risk Questionnaire (AIRQ) at screening and randomization is 2 or higher. If screening and randomization happen on the same day, the questionnaire will only be completed once.I am not pregnant and agree to use birth control during the study.I do not have severe lung diseases or other serious health conditions that could affect my participation.I use a quick-relief inhaler mainly to prevent breathing problems during exercise.I am currently pregnant or breastfeeding.I was hospitalized for asthma recently or had a severe asthma attack before.I have undergone bronchothermoplasty.I am currently on strong medication that affects liver enzyme activity.I've used a quick-relief inhaler more than once for symptoms in the last 2 weeks.I have been diagnosed with asthma by a doctor.I have used steroids for asthma or another condition in the last 6 weeks.I use a quick-relief inhaler, with or without long-term asthma control medication.
Research Study Groups:
This trial has the following groups:- Group 1: PT027
- Group 2: PT007
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Asthma Patient Testimony for trial: Trial Name: NCT05505734 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many places is this clinical trial taking place?
"To make things more convenient for patients, the 15 sites conducting this trial are situated near major population centres. If you choose to enroll in the study, you can minimize travel by selecting a site nearest to your location."
Answered by AI
How large is the study's subject pool?
"In order to accurately test the efficacy of this medication, we require 1910 patients that fit our inclusion criteria. These individuals can receive treatment at locations such as Meridian Clinical Research in Endwell, New york and Texas Health Care, PLLC d/b/a Privia Medical Group- North Texas in Fort Worth, Maryland."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
California
Utah
What site did they apply to?
Science 37
Monroe Biomedical Research
Hatboro Medical Associates
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
Why did patients apply to this trial?
A trial that is. A trial that is close by. I've been told that the albuterol will scar my lungs, so I'm hoping to control it better.
PatientReceived 1 prior treatment
After having COVID for the fourth time, and pneumonia for the second time (in Nov./Dec. 2023), I my fatigue and asthma symptoms have intensified. I have tried a few different inhalers, as well as been on oral steroids, but have not improved.
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Science 37: < 48 hours
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