Back to resultsA Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine (Epinephrine)
Primary Purpose
Anaphylaxis
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Epinephrine
Sponsored by
About this trial
This is an interventional treatment trial for Anaphylaxis focused on measuring Intranasal epinephrine, Plasma epinephrine level
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects
- 18-30 years-old
Exclusion Criteria:
- Pregnancy
- Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine
Sites / Locations
- Facaulty of Medicine, Siriraj Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
epinephrine IN, epinephrine IM, saline IN
Arm Description
Intranasal saline Intramuscular epinephrine Intranasal epinephrine
Outcomes
Primary Outcome Measures
Composite of Pharmacokinetics of epinephrine
Cmax, Area Under Curve, Tmax of epinephrine compare between 0.3 mg intramuscular and 5 mg intranasal route
Secondary Outcome Measures
Numbers of participants with adverse events as a measure of safety and tolerability
Any side effects from such administration such as bad smelling, sorethroat.
Full Information
NCT ID
NCT01432522
First Posted
January 19, 2011
Last Updated
September 12, 2011
Sponsor
Siriraj Hospital
Collaborators
Mahidol University
1. Study Identification
Unique Protocol Identification Number
NCT01432522
Brief Title
A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine
Acronym
Epinephrine
Official Title
Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siriraj Hospital
Collaborators
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaphylaxis
Keywords
Intranasal epinephrine, Plasma epinephrine level
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
epinephrine IN, epinephrine IM, saline IN
Arm Type
Experimental
Arm Description
Intranasal saline
Intramuscular epinephrine
Intranasal epinephrine
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Other Intervention Name(s)
adrenaline
Intervention Description
Intranasal epinephrine 5 mg /spray
Intramuscular epinephrine 0.3 mg
Intranasal saline spray
Primary Outcome Measure Information:
Title
Composite of Pharmacokinetics of epinephrine
Description
Cmax, Area Under Curve, Tmax of epinephrine compare between 0.3 mg intramuscular and 5 mg intranasal route
Time Frame
predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose
Secondary Outcome Measure Information:
Title
Numbers of participants with adverse events as a measure of safety and tolerability
Description
Any side effects from such administration such as bad smelling, sorethroat.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects
18-30 years-old
Exclusion Criteria:
Pregnancy
Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pakit Vichyanond, MD.
Organizational Affiliation
Siriraj medical school, Mahidol Univrsity
Official's Role
Study Director
Facility Information:
Facility Name
Facaulty of Medicine, Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
11692118
Citation
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.
Results Reference
result
PubMed Identifier
16461140
Citation
Rawas-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 Reference
result
PubMed Identifier
11061773
Citation
Simons 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 Reference
result
PubMed Identifier
3782679
Citation
Heilborn 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.
Results Reference
result
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A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine
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