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45th Multicenter Airway Research Collaboration

RecruitingPhase 4

Sponsor: Massachusetts General Hospital

Conditions: Asthma Acute, Asthma Exacerbation, Asthma, Asthma Control Level

Interventions: Airsupra

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 54 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

Cleveland, Ohio, United States