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NCT01705964 · ClinicalTrials.gov registry record · Phase 4
Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
A Phase 4 study, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 4
- Development phase
- 49
- Enrollment target
NCT01705964: Completed Phase 4 study, sponsored by University of Louisville.
NCT01705964 is a Phase 4 study that has completed, run by University of Louisville. The registered enrollment target is 49 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01705964, a Phase 4 study, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 49 participants
- Enrollment target
Study Summary
Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled bronchodilators (β2 agonists) for children with severe asthma exacerbation. Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2 agonists) for children with severe asthma exacerbation. Intervention: Subjects will be randomly assigned (50% chance) to receive a weight based dose of IM epinephrine 1:1000 or no adjunctive medication. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle. In addition to the study intervention, the standardized treatment pathway based on the current asthma guidelines in use at the investigator's center will be utilized. This pathway includes nebulized albuterol, ipratropium bromide, and systemic corticosteroids. The duration and dosages of these other interventions will be administered at the discretion of the treating provider.
Primary Outcome
Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15).
Interventions
- OTHER No intervention
- DRUG IM epinephrine 1:1000
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2013-06 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 4 |
What the finished NCT01705964 record still lists
NCT01705964 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which No intervention is the first listed.
NCT01705964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01705964 about?
NCT01705964 is a clinical study titled "Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation". Project Aim: To determine if intramuscular epinephrine is an effective adjunct to inhaled bronchodilators (β2 agonists) for children with severe asthma exacerbation. Hypothesis: IM epinephrine is an efficacious adjunct to inhaled bronchodilators (β2 agonists) for children with severe asthma exacerb...
What is the current status of trial NCT01705964?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 49 participants. The study started on 2013-06. Estimated completion is 2018-04-30.
What interventions are being tested in trial NCT01705964?
The interventions under investigation include: No intervention (OTHER), IM epinephrine 1:1000 (DRUG).
Who is sponsoring clinical trial NCT01705964?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01705964's enrollment target sits among peer trials
49 1323rd of 2000 higher than 670 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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