45th Multicenter Airway Collaboration on ED initiation of Airsupra
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
PHASE4 · Massachusetts General Hospital · NCT07166939
This trial tests whether giving Airsupra in the emergency department reduces asthma recurrence over three months for adults sent home on a short course of steroids.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1860 (estimated) |
| Ages | 18 Years to 54 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Drugs / interventions | prednisone |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07166939 on ClinicalTrials.gov |
What this trial studies
This is a cluster-randomized, open-label trial comparing ED initiation of Airsupra (combined albuterol+budesonide MDI) versus usual care for adults with acute asthma who are being discharged on short-course systemic corticosteroids. Participating emergency departments are randomized to offer Airsupra as the patient’s rescue inhaler with instruction and demonstration of MDI technique, while control sites provide usual discharge care. The primary outcome is acute asthma “recurrence” at three months, with secondary outcomes including short-term relapse and measures of asthma control. Eligible participants are English- or Spanish-speaking adults age 18–54 without COPD or other major exclusions and willing to use Airsupra for three months.
Who should consider this trial
Good fit: Ideal candidates are adults 18–54 presenting to a participating ED with acute asthma who are being discharged on a short course of systemic corticosteroids and can demonstrate correct MDI use.
Not a fit: Patients with chronic obstructive pulmonary disease, recent steroid use, concurrent pneumonia, significant cardiac or cancer comorbidities, or known hypersensitivity to study medications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, ED initiation of Airsupra could lower return visits and improve asthma control by combining quick relief and inhaled steroid therapy in one inhaler.
How similar studies have performed: Prior randomized trials and a Cochrane meta-analysis suggested that initiating inhaled corticosteroids at ED discharge may modestly reduce short-term relapse, but ED initiation of a combined albuterol+budesonide inhaler is a more recent approach with limited large-scale evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cleveland, Ohio
- MetroHealth — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Study coordinator: Carlos A Camargo, MD, DrPH
- Email: ccamargo@mgb.org
- Phone: 617-726-5276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Asthma Acute, Asthma Exacerbation, Asthma, Asthma Control Level, asthma, emergency department, airsupra, randomized trial