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

NCT01432522 | Completed

• 1 other identifier: 078/2550
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaphylaxis

Keywords

Intranasal epinephrine; Plasma epinephrine level

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Numbers of participants with adverse events as a measure of safety and tolerability

  1 year

Study Arms (1)

epinephrine IN, epinephrine IM, saline IN

EXPERIMENTAL

1. Intranasal saline 2. Intramuscular epinephrine 3. Intranasal epinephrine

Drug: Epinephrine

Interventions

Epinephrine DRUG

1. Intranasal epinephrine 5 mg /spray 2. Intramuscular epinephrine 0.3 mg 3. Intranasal saline spray

Also known as: adrenaline

epinephrine IN, epinephrine IM, saline IN

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects
• years-old

You may not qualify if:

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

Sponsors & Collaborators

• Siriraj Hospital: lead
• Mahidol University: collaborator

Study Sites (1)

Facaulty of Medicine, Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

Related Publications (4)

• 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.

  PMID: 11692118 RESULT

• 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.

  PMID: 16461140 RESULT

• 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.

  PMID: 11061773 RESULT

• 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.

  PMID: 3782679 RESULT

MeSH Terms

Conditions

Anaphylaxis

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Pakit Vichyanond, MD.

  Siriraj medical school, Mahidol Univrsity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: September 13, 2011
• Study Start: July 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 13, 2011

Record last verified: 2011-09

Locations

TH (1)