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45th Multicenter Airway Research Collaboration

ConditionsAsthma AcuteAsthma ExacerbationAsthmaAsthma Control Level
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-54
SponsorMassachusetts General Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Airsupra

    Drug

    1 dose (2 inhalations) PRN, with maximum of 6 doses (12 inhalations) in a 24-hour period

Treatment groups

1,860 Participants
are divided into 2 treatment groups
Group A: Usual careNo intervention 0 interventions
Group B: InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

acute asthma recurrence

any urgent or unscheduled visit to a clinician for worsening asthma symptoms during the 3 months after the index ED visit

Time frame
3 months

Secondary outcomes

1

asthma control

asthma control at 3 months after the index ED visit, as measured by AIRQ

Time frame
3 months
2

acute asthma relapse

any urgent or unscheduled visit to a clinician for worsening asthma symptoms during the 3 weeks after the index ED visit

Time frame
3 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov
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