Asthma in ChildrenPhase 2T-RECSNCT06074185
Treating Respiratory Emergencies in Children Study
A Phase 2 study testing Ipratropium Bromide in people with Asthma in Children, run by Oregon Health and Science University at 3 sites in United States.
Trial summary
Over 200,000 children have a 911 Emergency Medical Services (EMS) activation for respiratory distress each year, most of whom have acute wheezing. Early treatment in the prehospital setting could more rapidly relieve respiratory distress symptoms, prevent hypoxia, reduce invasive interventions, and reduce the need to… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Ipratropium Bromide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Jan 2024to 11 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 2-17 years; AND
- Transported by EMS through 911 activation; AND
- Prior history of wheeze/asthma, current asthma symptoms (dyspnea or wheeze); AND
- At least 4 of the following:
- Visible use of accessory muscles/retractions
- Inspiratory and expiratory wheezing or silent chest
Show all 11Show fewer
- Abnormal respiratory rate for age
- For < 6 years ≥ 46 breaths/min
- For ≥ 6 years ≥ 36 breaths/min
- Agitation, drowsiness, or confusion
- Oxygen saturation < 93% on room air
Who cannot join
- History of albuterol, ipratropium, or dexamethasone allergy
- Known or suspected pregnancy
- Prisoner
- Croup
- Suspected airway foreign body
- Respiratory distress not due to bronchospasm/wheeze
- Parent, legally authorized representative (LAR), subject, and/or family member objects to participation prior to treatment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University at Buffalo
Buffalo, New York, 14261
Mecklenburg County EMS
Charlotte, North Carolina, 28208
University of Utah
Salt Lake City, Utah, 84112
About this study
Over 200,000 children have a 911 Emergency Medical Services (EMS) activation for respiratory distress each year, most of whom have acute wheezing. Early treatment in the prehospital setting could more rapidly relieve respiratory distress symptoms, prevent hypoxia, reduce invasive interventions, and reduce the need to be hospitalized, thereby facilitating earlier return to normal daily activities. Preliminary data from one site found hospital admission was reduced from 30% to 21% among children when an EMS system introduced a pediatric asthma protocol with oral dexamethasone. The current standard for Emergency Department (ED) treatment for acute wheezing for children two and older includes inhaled ipratropium and dexamethasone. These treatments have a longstanding history of safety and are effective in preventing hospitalization when used early in the ED. Specific treatment protocols generally direct prehospital care. Ipratropium and dexamethasone are recommended by national EMS organizations that develop model protocols for prehospital care. However, only 25% of EMS agencies from large US metropolitan areas allow ipratropium, and only 10% include dexamethasone in their treatment protocols. A clinical trial is critically needed to evaluate whether the significant EMS resources required to implement interventions for children with life-threatening wheezing that have proven benefit in the ED result in improved patient outcomes. The overall objective of this three-site pilot trial is to address specific questions related to the implementation of the study and ensure its feasibility. The study will be conducted in the Pediatric Emergency Care Applied Research Network (PECARN) EMS Affiliates (EMSAs). The investigators will include patients aged 2-17 who have a 911 call for acute life-threatening wheezing. The specific aims are 1) to develop and produce a prehospital checklist for the treatment bundle, including ipratropium and dexamethasone, 2) to determine the feasibility of collecting patient outcomes for wheezing children treated in the EMS system, and 3) to evaluate the implementation of the EMS treatment bundle and checklist using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Our overall hypothesis is that the study will be feasible to implement. This study will provide the necessary data to ensure the eventual trial is feasible, primarily by establishing the ability to measure the outcomes of interest as well as evaluating implementation. This study is innovative by focusing on pediatric care in the prehospital environment, a critical component of our emergency care system that is often neglected in research.
- Conditions
- Asthma in Children
- Being tested
- Ipratropium Bromide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipratropium BromideDrug
Also called dexamethasone
The study intervention involves implementing a treatment bundle that includes inhaled ipratropium bromide and dexamethasone.
| Study group | Role | What they receive |
|---|---|---|
| Continue current care | No intervention | In this arm, participants will be treated using the existing EMS protocol, and evaluate patient outcomes. |
| Treatment bundle and checklist | Experimental | In this arm, we will implement a new treatment protocol with the study bundle, and evaluate patient outcomes. Receives: Drug: Ipratropium Bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Admitted to the Hospital in Each Group
Whether or not the patient was admitted to the hospital after the index EMS encounter
Measured: Within 24 hours of the index EMS encounter
Secondary outcomes (1)
NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) Asthma Impact Scale
Quality of life score for asthma. Range 0-100. A higher score equates to poorer quality of life.
Measured: 6-8 days after the index EMS encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start19 Jan 2024
- Primary completion28 Feb 2025
- Study completion11 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a before-and-after study
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, University at Buffalo, Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Matt Hansen, Oregon Health and Science University
- Investigators
- Matthew L Hansen, MD, MCR, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074185
- Sponsor's protocol ID
- 00138724
- Acronym
- T-RECS
- Status last verified
- Apr 2026
- First submitted
- 10 Aug 2023
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hansen M, Jacobsen K, Freeman S, Studnek J, Swanson D, Ranjit C, Crady R, Burnett SJ, Clemency B, Becker S, Brant-Zawadzki G, Jung J, Barney BJ. Treating Respiratory Emergencies in Children Study (T-RECS): a pilot trial of prehospital treatment for life-threatening pediatric asthma. J Asthma. 2026 Apr 22:1-9. doi: 10.1080/02770903.2026.2654585. Online ahead of print.
PubMed 41943480
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Respiratory Emergencies in Children Study
- ClinicalTrials.gov ID
- NCT06074185
- Acronym / sponsor ID
- T-RECS / 00138724
- Conditions
- Asthma in Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- University of Utah, University at Buffalo, Wake Forest University Health Sciences
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 11 Mar 2025 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Posted 24 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over 200,000 children have a 911 Emergency Medical Services (EMS) activation for respiratory distress each year, most of whom have acute wheezing. Early treatment in the prehospital setting could more rapidly relieve respiratory distress symptoms, prevent hypoxia, reduce invasive interventions, and reduce the need to be hospitalized, thereby facilitating earlier return to normal daily activities. Preliminary data from one site found hospital admission was reduced from 30% to 21% among children when an EMS system introduced a pediatric asthma protocol with oral dexamethasone. The current standard for Emergency Department (ED) treatment for acute wheezing for children two and older includes inhaled ipratropium and dexamethasone. These treatments have a longstanding history of safety and are effective in preventing hospitalization when used early in the ED. Specific treatment protocols generally direct prehospital care. Ipratropium and dexamethasone are recommended by national EMS organizations that develop model protocols for prehospital care. However, only 25% of EMS agencies from large US metropolitan areas allow ipratropium, and only 10% include dexamethasone in their treatment protocols. A clinical trial is critically needed to evaluate whether the significant EMS resources required to implement interventions for children with life-threatening wheezing that have proven benefit in the ED result in improved patient outcomes. The overall objective of this three-site pilot trial is to address specific questions related to the implementation of the study and ensure its feasibility. The study will be conducted in the Pediatric Emergency Care Applied Research Network (PECARN) EMS Affiliates (EMSAs). The investigators will include patients aged 2-17 who have a 911 call for acute life-threatening wheezing. The specific aims are 1) to develop and produce a prehospital checklist for the treatment bundle, including ipratropium and dexamethasone, 2) to determine the feasibility of collecting patient outcomes for wheezing children treated in the EMS system, and 3) to evaluate the implementation of the EMS treatment bundle and checklist using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Our overall hypothesis is that the study will be feasible to implement. This study will provide the necessary data to ensure the eventual trial is feasible, primarily by establishing the ability to measure the outcomes of interest as well as evaluating implementation. This study is innovative by focusing on pediatric care in the prehospital environment, a critical component of our emergency care system that is often neglected in research.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a before-and-after study
| Arm | Type | Receives |
|---|---|---|
| Continue current care | No intervention | –In this arm, participants will be treated using the existing EMS protocol, and evaluate patient outcomes. |
| Treatment bundle and checklist | Experimental | Drug: Ipratropium BromideIn this arm, we will implement a new treatment protocol with the study bundle, and evaluate patient outcomes. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Ages 2-17 years; AND
- Transported by EMS through 911 activation; AND
- Prior history of wheeze/asthma, current asthma symptoms (dyspnea or wheeze); AND
- At least 4 of the following:
Key exclusion criteria (7 listed)
- History of albuterol, ipratropium, or dexamethasone allergy
- Known or suspected pregnancy
- Prisoner
- Croup
- Suspected airway foreign body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ipratropium BromideAlso: dexamethasoneThe study intervention involves implementing a treatment bundle that includes inhaled ipratropium bromide and dexamethasone. | Drug | Treatment bundle and checklist |
Primary outcome
Proportion of Patients Admitted to the Hospital in Each Group
Time frame: Within 24 hours of the index EMS encounter
Whether or not the patient was admitted to the hospital after the index EMS encounter
1 secondary outcome
NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) Asthma Impact Scale
Time frame: 6-8 days after the index EMS encounter
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41943480Hansen M, Jacobsen K, Freeman S, Studnek J, Swanson D, Ranjit C, Crady R, Burnett SJ, Clemency B, Becker S, Brant-Zawadzki G, Jung J, Barney BJ. Treating Respiratory Emergencies in Children Study (T-RECS): a pilot trial of prehospital treatment for life-threatening pediatric asthma. J Asthma. 2026 Apr 22:1-9. doi: 10.1080/02770903.2026.2654585. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew L Hansen, MD, MCR principal investigator
Oregon Health and Science University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipratropium Bromide in people with Asthma in Children, run by Oregon Health and Science University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Admitted to the Hospital in Each Group (time frame: Within 24 hours of the index EMS encounter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06074185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.