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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01432522
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : September 13, 2011
Mahidol University
Information provided by (Responsible Party):
Pakit Vichyanond, MD, Siriraj Hospital

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.

Condition or disease Intervention/treatment Phase
Anaphylaxis Drug: Epinephrine Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Absorption of Epinephrine Into the Circulation After Epinephrine Intranasal Spray Administration and After Intramuscular Injection
Study Start Date : July 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: epinephrine IN, epinephrine IM, saline IN
  1. Intranasal saline
  2. Intramuscular epinephrine
  3. Intranasal epinephrine
Drug: Epinephrine
  1. Intranasal epinephrine 5 mg /spray
  2. Intramuscular epinephrine 0.3 mg
  3. Intranasal saline spray
Other Name: adrenaline

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Numbers of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ]
    Any side effects from such administration such as bad smelling, sorethroat.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01432522

Facaulty of Medicine, Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Siriraj Hospital
Mahidol University
Study Director: Pakit Vichyanond, MD. Siriraj medical school, Mahidol Univrsity

Publications of Results:
Responsible Party: Pakit Vichyanond, MD, Professor of Pediatrics, Siriraj Hospital Identifier: NCT01432522     History of Changes
Other Study ID Numbers: 078/2550
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: September 13, 2011
Last Verified: September 2011

Keywords provided by Pakit Vichyanond, MD, Siriraj Hospital:
Intranasal epinephrine
Plasma epinephrine level

Additional relevant MeSH terms:
Hypersensitivity, Immediate
Immune System Diseases
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents