45th Multicenter Airway Collaboration on ED initiation of Airsupra

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• MetroHealth
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Carlos A Camargo, MD, DrPH
• Email: ccamargo@mgb.org
• Phone: 617-726-5276

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.