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

This study has been completed.

Sponsor:

Collaborator:

Mahidol University

Information provided by (Responsible Party):

Pakit Vichyanond, MD, Siriraj Hospital

ClinicalTrials.gov Identifier:

NCT01432522

First received: January 19, 2011

Last updated: September 12, 2011

Last verified: September 2011

History of Changes

Purpose

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.

Condition	Intervention
Anaphylaxis	Drug: Epinephrine

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection

Resource links provided by NLM:

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Racepinephrine hydrochloride Racepinephrine

U.S. FDA Resources

Further study details as provided by Siriraj Hospital:

Primary Outcome Measures:

Composite of Pharmacokinetics of epinephrine [ Time Frame: predose, 5 , 10, 15, 20, 30, 45, 60, 90, 120, 180 minutes post-dose ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Any side effects from such administration such as bad smelling, sorethroat.

Estimated Enrollment:	12
Study Start Date:	July 2010
Study Completion Date:	September 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: epinephrine IN, epinephrine IM, saline IN Intranasal saline Intramuscular epinephrine Intranasal epinephrine	Drug: Epinephrine Intranasal epinephrine 5 mg /spray Intramuscular epinephrine 0.3 mg Intranasal saline spray Other Name: adrenaline

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.

Eligibility

Ages Eligible for Study:	18 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432522

Locations

Thailand
Facaulty of Medicine, Siriraj Hospital
Bangkok, Thailand, 10700

Sponsors and Collaborators

Siriraj Hospital

Mahidol University

Investigators

Study Director:

Pakit Vichyanond, MD.

Siriraj medical school, Mahidol Univrsity

More Information

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.

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.

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.

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.

Responsible Party:	Pakit Vichyanond, MD, Professor of Pediatrics, Siriraj Hospital
ClinicalTrials.gov Identifier:	NCT01432522 History of Changes
Other Study ID Numbers:	078/2550
Study First Received:	January 19, 2011
Last Updated:	September 12, 2011
Health Authority:	Thailand: Ethical Committee

Keywords provided by Siriraj Hospital:

Intranasal epinephrine
Plasma epinephrine level

Additional relevant MeSH terms:

Anaphylaxis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Epinephrine
Epinephryl borate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013

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