A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine

Anaphylaxis Clinical Trial

— Epinephrine  

Official title:

Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432522
• Other study ID #: 078/2550
• Status: Completed
• Phase: N/A
• First received: January 19, 2011
• Last updated: September 12, 2011
• Start date: July 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Siriraj Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

1. Healthy subjects

2. 18-30 years-old

Exclusion Criteria:

1. Pregnancy

2. Subjected who use current medication that interfere with result of plasma epinephrine level such as pseudoephedrine

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaphylaxis

Intervention

Drug:
• Epinephrine
Intranasal epinephrine 5 mg /spray Intramuscular epinephrine 0.3 mg Intranasal saline spray

Locations

Country	Name	City	State
Thailand	Facaulty of Medicine, Siriraj Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Siriraj Hospital	Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Pharmacokinetics of epinephrine	Cmax, Area Under Curve, Tmax of epinephrine compare between 0.3 mg intramuscular and 5 mg intranasal route	predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose	Yes
Secondary	Numbers of participants with adverse events as a measure of safety and tolerability	Any side effects from such administration such as bad smelling, sorethroat.	1 year	Yes