Recruiting

Airsupra

Sponsor:

Massachusetts General Hospital

Code:

NCT07166939

Conditions

Asthma Acute

Asthma Exacerbation

Asthma

Asthma Control Level

Eligibility Criteria

Sex: All

Age: 18 - 54

Healthy Volunteers: Not accepted

Interventions

Airsupra

Study Details

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).

Conditions

Asthma Acute

Asthma Exacerbation

Asthma

Asthma Control Level

Study ID

NCT07166939

Start date

Nov 7, 2025

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 54

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1860 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Usual care

usual care

active comparator: Intervention

Airsupra PRN

Interventions

Airsupra

1 dose (2 inhalations) PRN, with maximum of 6 doses (12 inhalations) in a 24-hour period

Primary outcome measure

  • acute asthma recurrence [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Carlos A Camargo, MD, DrPH

617-726-5276ccamargo@mgb.org

Locations

MetroHealth

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Charles L Emerman, MD

617-726-5276cemerman@metrohealth.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • asthma
  • emergency department
  • airsupra
  • randomized trial
  • acute asthma recurrence
  • acute asthma relapse
  • asthma control
  • acute asthma
  • asthma exacerbation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-04-17.