AnaphylaxisEpinephrineNCT01432522
A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine
A study testing Epinephrine in people with Anaphylaxis, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
This study is a preliminary report of pharmacokinetic data of epinephrine administered via intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaphylaxis
- What is being tested?
- Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2010to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- 18-30 years-old
Who cannot join
- Pregnancy
- Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Facaulty of Medicine, Siriraj Hospital
Bangkok, Bangkok, 10700
About this study
Official title: Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection
This study is a preliminary report of pharmacokinetic data of epinephrine administered via intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.
Read the detailed description
Patients are reluctant to use Epipen® on emergency basis, perhaps because of improperly training, hesitancy and fear of needle. Other route of administration of epinephrine (EPI) may be more benefit such as intranasal route.
- Conditions
- Anaphylaxis
- Being tested
- Epinephrine
- Keywords
- Intranasal epinephrine, Plasma epinephrine level
- Medical subject headings
- Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
Also called adrenaline
- Intranasal epinephrine 5 mg /spray
- Intramuscular epinephrine 0.3 mg
- Intranasal saline spray
| Study group | Role | What they receive |
|---|---|---|
| epinephrine IN, epinephrine IM, saline IN | Experimental | 1. Intranasal saline
2. Intramuscular epinephrine
3. Intranasal epinephrine Receives: Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Pharmacokinetics of epinephrine
Cmax, Area Under Curve, Tmax of epinephrine compare between 0.3 mg intramuscular and 5 mg intranasal route
Measured: predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose
Secondary outcomes (1)
Numbers of participants with adverse events as a measure of safety and tolerability
Any side effects from such administration such as bad smelling, sorethroat.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startJul 2010
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnaphylaxisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol University
- Responsible party
- Principal investigator, Pakit Vichyanond, MD, Siriraj Hospital
- Investigators
- Pakit Vichyanond, MD., Study director, Siriraj medical school, Mahidol Univrsity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432522
- Sponsor's protocol ID
- 078/2550
- Acronym
- Epinephrine
- Status last verified
- Sep 2011
- First submitted
- 19 Jan 2011
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Simons FE, Gu X, Simons KJ. Epinephrine absorption in adults: intramuscular versus subcutaneous injection. J Allergy Clin Immunol. 2001 Nov;108(5):871-3. doi: 10.1067/mai.2001.119409.
PubMed 11692118Rawas-Qalaji MM, Simons FE, Simons KJ. Sublingual epinephrine tablets versus intramuscular injection of epinephrine: dose equivalence for potential treatment of anaphylaxis. J Allergy Clin Immunol. 2006 Feb;117(2):398-403. doi: 10.1016/j.jaci.2005.12.1310.
PubMed 16461140Simons FE, Gu X, Johnston LM, Simons KJ. Can epinephrine inhalations be substituted for epinephrine injection in children at risk for systemic anaphylaxis? Pediatrics. 2000 Nov;106(5):1040-4. doi: 10.1542/peds.106.5.1040.
PubMed 11061773Heilborn H, Hjemdahl P, Daleskog M, Adamsson U. Comparison of subcutaneous injection and high-dose inhalation of epinephrine--implications for self-treatment to prevent anaphylaxis. J Allergy Clin Immunol. 1986 Dec;78(6):1174-9. doi: 10.1016/0091-6749(86)90268-x.
PubMed 3782679
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection
- ClinicalTrials.gov ID
- NCT01432522
- Acronym / sponsor ID
- Epinephrine / 078/2550
- Conditions
- Anaphylaxis
- Keywords
- Intranasal epinephrine, Plasma epinephrine level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Collaborators
- Mahidol University
- Study start
- Jul 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 13 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a preliminary report of pharmacokinetic data of epinephrine administered via intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.
Detailed description
Patients are reluctant to use Epipen® on emergency basis, perhaps because of improperly training, hesitancy and fear of needle. Other route of administration of epinephrine (EPI) may be more benefit such as intranasal route.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epinephrine IN, epinephrine IM, saline IN | Experimental | Drug: Epinephrine1. Intranasal saline 2. Intramuscular epinephrine 3. Intranasal epinephrine |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects
- 18-30 years-old
Key exclusion criteria (2 listed)
- Pregnancy
- Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine
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 |
|---|---|---|
| EpinephrineAlso: adrenaline1. Intranasal epinephrine 5 mg /spray 2. Intramuscular epinephrine 0.3 mg 3. Intranasal saline spray | Drug | epinephrine IN, epinephrine IM, saline IN |
Primary outcome
Composite of Pharmacokinetics of epinephrine
Time frame: predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose
Cmax, Area Under Curve, Tmax of epinephrine compare between 0.3 mg intramuscular and 5 mg intranasal route
1 secondary outcome
Numbers of participants with adverse events as a measure of safety and tolerability
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2011.
- Results publication: PubMed 11692118Simons FE, Gu X, Simons KJ. Epinephrine absorption in adults: intramuscular versus subcutaneous injection. J Allergy Clin Immunol. 2001 Nov;108(5):871-3. doi: 10.1067/mai.2001.119409.
- Results publication: PubMed 16461140Rawas-Qalaji MM, Simons FE, Simons KJ. Sublingual epinephrine tablets versus intramuscular injection of epinephrine: dose equivalence for potential treatment of anaphylaxis. J Allergy Clin Immunol. 2006 Feb;117(2):398-403. doi: 10.1016/j.jaci.2005.12.1310.
- Results publication: PubMed 11061773Simons FE, Gu X, Johnston LM, Simons KJ. Can epinephrine inhalations be substituted for epinephrine injection in children at risk for systemic anaphylaxis? Pediatrics. 2000 Nov;106(5):1040-4. doi: 10.1542/peds.106.5.1040.
- Results publication: PubMed 3782679Heilborn H, Hjemdahl P, Daleskog M, Adamsson U. Comparison of subcutaneous injection and high-dose inhalation of epinephrine--implications for self-treatment to prevent anaphylaxis. J Allergy Clin Immunol. 1986 Dec;78(6):1174-9. doi: 10.1016/0091-6749(86)90268-x.
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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.
Pakit Vichyanond, MD. study director
Siriraj medical school, Mahidol Univrsity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epinephrine in people with Anaphylaxis, run by Siriraj Hospital at 1 site in Thailand.
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 2 inclusion and 2 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 13 Sep 2011. 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 Thailand. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite of Pharmacokinetics of epinephrine (time frame: predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose). 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 NCT01432522, which also lists 4 linked publications.
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 13 Sep 2011.