BridgeMD
New treatment option for Asthma Acute
Official title 45th Multicenter Airway Research Collaboration
ClinicalTrials.gov ID: NCT07166939
What this study is testing
What is Airsupra?
Airsupra is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for asthma acute.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is a randomized controlled trial on the effect of emergency department initiation of Airsupra on acute asthma "recurrence" at 3 months and other related outcomes (acute asthma relapse, asthma control).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 54
You may be able to join if
- acute asthma
- age 18.0 to 54.9 years
- English and/or Spanish speaking
- decision by ED attending to discharge patient to home on short course of systemic corticosteroids
- (intervention group only) Willingness to use Airsupra as their rescue inhaler for next 3 months
You likely can't join if
- involvement in the planning and/or conduct of the study
- previous enrolment in the present study
- prior diagnosis of COPD, chronic bronchitis, or emphysema
- use of systemic corticosteroids in the past 2 weeks
- participation in another clinical study with an investigational product during the past 4 weeks or the 3 months after enrollment in the current study
- concurrent pneumonia
See the full eligibility criteria
- acute asthma
- age 18.0 to 54.9 years
- English and/or Spanish speaking
- decision by ED attending to discharge patient to home on short course of systemic corticosteroids
- (intervention group only) Willingness to use Airsupra as their rescue inhaler for next 3 months
- demonstration of acceptable MDI administration technique
- provision of informed consent prior to any study-specific procedures
- involvement in the planning and/or conduct of the study
- previous enrolment in the present study
- prior diagnosis of COPD, chronic bronchitis, or emphysema
- use of systemic corticosteroids in the past 2 weeks
- participation in another clinical study with an investigational product during the past 4 weeks or the 3 months after enrollment in the current study
- concurrent pneumonia
- clinically significant cardiovascular disease or clinically significant cancer
- patients with known hypersensitivity to Airsupra, albuterol sulfate, budesonide, or any of the excipients of the product
- (for women only, by self-report):
- currently pregnant
- currently breastfeeding,
- (among sexually active women of child-bearing age only) not using adequate contraception over the last 3 months, or no plan to use adequate contraception over the next 3 months
- lack of a working cell phone and working email address
- expected lack of availability for text and/or telephone follow-up at approximately 3, 6, and 12 weeks after the ED visit
- inability to provide an alternate contact with a working cell phone and working email address.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 54 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.