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

NCT ID: NCT01432522

Last Updated: 2011-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Anaphylaxis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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epinephrine IN, epinephrine IM, saline IN

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

Group Type EXPERIMENTAL

Epinephrine

Intervention Type DRUG

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

Interventions

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Epinephrine

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

Intervention Type DRUG

Other Intervention Names

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adrenaline

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role collaborator

Siriraj Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pakit Vichyanond, MD

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pakit Vichyanond, MD.

Role: STUDY_DIRECTOR

Siriraj medical school, Mahidol Univrsity

Locations

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Facaulty of Medicine, Siriraj Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type RESULT
PMID: 11692118 (View on PubMed)

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.

Reference Type RESULT
PMID: 16461140 (View on PubMed)

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.

Reference Type RESULT
PMID: 11061773 (View on PubMed)

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.

Reference Type RESULT
PMID: 3782679 (View on PubMed)

Other Identifiers

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078/2550

Identifier Type: -

Identifier Source: org_study_id

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