No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 54
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
1,860 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for
This trial is looking for adults with acute asthma to see if starting Airsupra in the emergency department helps prevent future asthma episodes. Participants will use Airsupra as their rescue inhaler for 3 months.
Are You a Good Fit for This Trial?
Must not be takingSystemic corticosteroids
Rules you outCOPDChronic bronchitisEmphysemaPneumoniaSignificant cardiovascular diseaseSignificant cancer
You may be able to join if
I have acute asthma
I am between 18 to 54 years old
I speak English or Spanish
I will be discharged from the emergency department with a short course of corticosteroids
I am willing to use Airsupra as my rescue inhaler for the next 3 months
I can demonstrate how to properly use an inhaler
I will provide informed consent to join the study
You may not be able to join if
I have been involved in planning or conducting this study
I have participated in this study before
I have been diagnosed with COPD, chronic bronchitis, or emphysema
I have used systemic corticosteroids in the past 2 weeks
I am in another clinical study with an investigational product
I currently have pneumonia
I have significant heart disease or cancer
I am currently pregnant or breastfeeding
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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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
* demon…
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.
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