AsthmaPhase 4NCT01705964
Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
A Phase 4 study testing IM epinephrine 1:1000 in people with Asthma, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- IM epinephrine 1:1000
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 30 Apr 2018
- Phase
- Phase 4
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age greater than 6 years and less than 18 years
- Pre-existing diagnosis of asthma
- Presenting to the ED with an asthma exacerbation
Who cannot join
- History of chronic lung or upper airway disease other than asthma
- History significant, uncorrected congenital heart disease or cardiac arrhythmia
- History of thyroid disease
- Impending respiratory failure
- Allergy to epinephrine
- Pregnancy
- PEFR>60% of predicted and clinical asthma score less than 8
Trial locations and contacts
1 site in 1 country.
United States1 site
Kosair Children's Hospital
Louisville, Kentucky, 40202
About this study
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.
Read more
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.
- Conditions
- Asthma
- Being tested
- IM epinephrine 1:1000, No intervention
- Keywords
- Status asthmaticus, Asthma exacerbation, Epinephrine, Adjunctive therapy
- Medical subject headings
- Asthma, Status Asthmaticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM epinephrine 1:1000Drug
IM epinephrine 1:1000. 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.
No interventionOther
A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.
| Study group | Role | What they receive |
|---|---|---|
| IM epinephrine 1:1000 | Experimental | IM epinephrine 1:1000. 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. Receives: Drug: IM epinephrine 1:1000 |
| No intervention | Sham comparator | A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15
Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15).
Measured: 15 minutes after the study intervention
Secondary outcomes (4)
Disposition
Disposition from the ED or rates of discharge.
Measured: At the time a dispostion from the ED is completed (usually within 4 hours of the study intervention)
Change in Percent of Predicted PEFR at t120
Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 120 minutes after study intervention compared to baseline
Measured: 120 minutes after the study intervention
Breaths Per Minute at t120
breaths per minute at t120 minutes compared to baseline
Measured: breaths per minute 120 minutes after the study intervention
Heart Rate at t120
Heart rate at t120 minutes in beats per minute (BPM)
Measured: up to 120 minutes after the study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startJun 2013
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
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.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerry Caperell, University of Louisville
- Investigators
- Kerry Caperell, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705964
- Sponsor's protocol ID
- Caperell-Epi-001
- Status last verified
- Jun 2021
- First submitted
- 9 Oct 2012
- Last updated
- 6 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular Epinephrine as an Adjunctive Treatment for Severe Pediatric Asthma Exacerbation
- ClinicalTrials.gov ID
- NCT01705964
- Acronym / sponsor ID
- Caperell-Epi-001
- Conditions
- Asthma
- Keywords
- Status asthmaticus, Asthma exacerbation, Epinephrine, Adjunctive therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Posted 6 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IM epinephrine 1:1000 | Experimental | Drug: IM epinephrine 1:1000IM epinephrine 1:1000. 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. |
| No intervention | Sham comparator | Other: No interventionA sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age greater than 6 years and less than 18 years
- Pre-existing diagnosis of asthma
- Presenting to the ED with an asthma exacerbation
Key exclusion criteria (7 listed)
- History of chronic lung or upper airway disease other than asthma
- History significant, uncorrected congenital heart disease or cardiac arrhythmia
- History of thyroid disease
- Impending respiratory failure
- Allergy to epinephrine
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 |
|---|---|---|
| IM epinephrine 1:1000IM epinephrine 1:1000. 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. | Drug | IM epinephrine 1:1000 |
| No interventionA sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group. | Other | No intervention |
Primary outcome
Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15
Time frame: 15 minutes after the study intervention
Change in percent of predicted Peak Expiratory Flow Rate (PEFR) 15 minutes after the study intervention (t15).
4 secondary outcomes
Disposition
Time frame: At the time a dispostion from the ED is completed (usually within 4 hours of the study intervention)
Change in Percent of Predicted PEFR at t120
Time frame: 120 minutes after the study intervention
Breaths Per Minute at t120
Time frame: breaths per minute 120 minutes after the study intervention
Heart Rate at t120
Time frame: up to 120 minutes after the study intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kerry Caperell, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IM epinephrine 1:1000 in people with Asthma, run by University of Louisville at 1 site 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 3 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 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 6 Jul 2021). 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?
Change in Percent of Predicted Peak Expiratory Flow Rate (PEFR) at t15 (time frame: 15 minutes after the study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2021.