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NCT07166939RecruitingPhase 4

45th Multicenter Airway Research Collaboration

A Phase 4, Multicenter, Cluster Randomized, Open-label, Intervention Versus Usual Care, Controlled Study on the Effect of Emergency Department Initiation of Airsupra on Asthma Outcomes

Source: ClinicalTrials.gov · Last updated 17 Apr 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
1860 (estimated)
First submitted
9 Sept 2025
Start date
7 Nov 2025
Primary completion date
Jun 2027
Lead sponsor
Massachusetts General Hospital
Diseases
Asthma
NCT number
NCT07166939

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 1860
  • From 7 Nov 2025 to the primary completion date, Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Age

  • (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

Other

  • involvement in the planning and/or conduct of the study
  • (for women only, by self-report):
  • currently pregnant
  • currently breastfeeding,
  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to 54 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
MetroHealth
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.