45th Multicenter Airway Research Collaboration

NCT07166939 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2025P002364
• Study Type: interventional
• Target: 1,860
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• acute asthma recurrence

  any urgent or unscheduled visit to a clinician for worsening asthma symptoms during the 3 months after the index ED visit

  3 months

Secondary Outcomes (2)

• asthma control

  3 months

• acute asthma relapse

  3 weeks

Study Arms (2)

Usual care

NO INTERVENTION

usual care

Intervention

ACTIVE COMPARATOR

Airsupra PRN

Drug: Airsupra

Interventions

Airsupra DRUG

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

Intervention

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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
• demonstration of acceptable MDI administration technique
• provision of informed consent prior to any study-specific procedures

You may not qualify 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
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MetroHealth

Cleveland, Ohio, 44109, United States

RECRUITING

MeSH Terms

Conditions

Asthma; Emergencies

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Carlos A Camargo, MD, DrPH

CONTACT

617-726-5276; ccamargo@mgb.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: cluster randomized trial

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 11, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)