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Bronchodilator

Ipratropium Bromide for Childhood Asthma (T-RECS Trial)

Phase 2

Recruiting

Led By Matthew L Hansen, MD, MCR

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Agitation, drowsiness, or confusion

Inspiratory and expiratory wheezing or silent chest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 hours of the index ems encounter

Awards & highlights

T-RECS Trial Summary

This trial will evaluate an EMS prehospital treatment for acute wheezing in children, to improve outcomes & reduce hospitalizations. It will assess the feasibility of the protocol & measure outcomes in EMS systems. Results will help ensure a future trial is feasible & focus on pediatric prehospital care.

Who is the study for?

This trial is for children aged 2-17 who experience severe asthma attacks and are transported by EMS after a 911 call. They must have a history of asthma or current symptoms, use accessory muscles to breathe, have an abnormal respiratory rate, or oxygen saturation below 93%. Children with allergies to the study drugs, pregnant individuals, prisoners, those with croup or foreign body in airway are excluded.Check my eligibility

What is being tested?

The trial tests if early treatment with Ipratropium Bromide and dexamethasone given by EMS can help kids having serious asthma attacks. It aims to see if this approach reduces hospital admissions and improves outcomes compared to current protocols that don't widely include these treatments.See study design

What are the potential side effects?

Ipratropium may cause dry mouth, coughing, headache; rarely it can lead to worsening breathing problems. Dexamethasone might result in mood changes, increased appetite, indigestion; long-term use could affect growth in children.

T-RECS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience agitation, drowsiness, or confusion.

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I experience wheezing or have a silent chest when breathing.

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I am between 2 and 17 years old.

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I use extra muscles to breathe or see my skin pull in with breaths.

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My breathing rate is not normal for my age.

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My breathing rate is 46 breaths per minute or more and I am under 6 years old.

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I am 6 years or older and breathe 36 times per minute or more.

T-RECS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 hours of the index ems encounter

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 hours of the index ems encounter

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hours of the index ems encounter for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients admitted to the hospital in each group

Secondary outcome measures

NIH Patient-Reported Outcomes Measurement Information Systems (PROMIS) asthma impact scale

Other outcome measures

Proportion of patients who require a critical care intervention

Rate of successful primary and measurement among participants

T-RECS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment bundle and checklistExperimental Treatment1 Intervention

In this arm, we will implement a new treatment protocol with the study bundle, and evaluate patient outcomes.

Group II: Continue current careActive Control1 Intervention

In this arm, participants will be treated using the existing EMS protocol, and evaluate patient outcomes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipratropium Bromide

2005

Completed Phase 4

~80

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

974 Previous Clinical Trials

7,385,762 Total Patients Enrolled

University of UtahOTHER

1,100 Previous Clinical Trials

1,778,551 Total Patients Enrolled

University at BuffaloOTHER

132 Previous Clinical Trials

98,829 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are adults aged 18 or above being included in the research?

"This clinical trial seeks to enroll children aged between 2 and 17, with a total of 90 participants in this age group. For those above the age of 65, there is an additional 150 positions available."

Answered by AI

Are any more participants being accepted for this research project?

"Clinicaltrials.gov states that this particular trial, first published on January 1st 2024 and last revised October 5th 2023 is not currently enrolling patients. Nevertheless, there are a total of 238 different medical studies actively recruiting volunteers at this time."

Answered by AI

Is my eligibility to join this trial accepted?

"The requirements for eligibility in this clinical trial include having been diagnosed with childhood asthma and being between 2-17 years old. Approximately 150 suitable candidates are necessary to fill the spots."

Answered by AI

What possible deleterious effects could result from Treatment bundle and checklist?

"While there is still much to learn about the efficacy of this treatment bundle and checklist, our team at Power has determined it's safety ratings to be a 2 based on existing evidence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treating Respiratory Emergencies in Children Study

2024. "Treating Respiratory Emergencies in Children Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06074185.