RightFit
RecruitingPhase 4

45th Multicenter Airway Research Collaboration

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 54 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Most follow-up assessments will be by telephone interview, but texts will be used per patient preference and/or to increase completeness of follow-up."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether starting Airsupra in the emergency department helps prevent another asthma attack over 3 months and improves asthma control. It is for adults ages 18 to 54 who have an asthma attack and are going home with a short course of steroid medicine. Participants are assigned to study groups by chance.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have an asthma attack.
  • Be age 18 to 54.
  • Speak English, Spanish, or both.
  • Have the emergency department doctor decide you can go home with a short course of steroid medicine that treats the whole body.
  • If assigned to the Airsupra group, agree to use it as your quick-relief inhaler for 3 months.
  • Show that you can use a metered-dose inhaler correctly. This inhaler gives a measured puff of medicine.
  • Give informed consent before any study procedures. This means you understand the study and agree to join.

Who can't join

  • Helped plan or run this study, or have already joined it before.
  • Have been diagnosed with COPD, chronic bronchitis, or emphysema. These are long-term lung diseases.
  • Used steroid medicine that treats the whole body in the past 2 weeks, or took part in another study testing a product in the past 4 weeks or during the 3 months after joining.
  • Have pneumonia, a lung infection; significant heart or blood vessel disease; or significant cancer.
  • Have a known allergy to Airsupra, albuterol sulfate, budesonide, or any other ingredient in Airsupra.
  • Are pregnant or breastfeeding. Sexually active women who can become pregnant also cannot join if they have not used adequate birth control for the past 3 months or do not plan to use it for the next 3 months.
  • Do not have both a working cell phone and email address, or cannot provide another contact person who has both.
  • Expect to be unavailable for follow-up by text or phone about 3, 6, and 12 weeks after the emergency department visit.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

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