NCT07166939 45th Multicenter Airway Research Collaboration
| NCT ID | NCT07166939 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Massachusetts General Hospital |
| Condition | Asthma Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,860 participants |
| Start Date | 2025-11-07 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,860 participants in total. It began in 2025-11-07 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
INCLUSION 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 EXCLUSION CRITERIA: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07166939 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 54 Years, studying Asthma Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07166939 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07166939 currently recruiting?
Yes, NCT07166939 is actively recruiting participants. Contact the research team at ccamargo@mgb.org for enrollment information.
Where is the NCT07166939 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07166939 clinical trial?
NCT07166939 is sponsored by Massachusetts General Hospital. The trial plans to enroll 1,860 participants.
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