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Validation of Laser Doppler Flowimetry to Identify Allergic Rhinitis Patients With Pharmacogenetic Alterations in Histamine Metabolism

This study is not yet open for participant recruitment.
Verified by Children's Mercy Hospital Kansas City, August 2006

Sponsored by: Children's Mercy Hospital Kansas City
Information provided by: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT00362999
  Purpose

The hypothesis to be proven is that histamine iontophoresis with measurement of microvascular blood flow by laser Doppler flowimetry can be used as a reliable marker to characterize the normal microvascular cutaneous response to histamine.


Condition
Allergic Rhinitis

ChemIDplus related topics:   Histamine    Histamine dihydrochloride    Histamine phosphate   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Screening, Cross-Sectional, Defined Population, Prospective Study
Official Title:   Histamine Pharmacodynamics in Patients With Allergic Rhinitis: Validation of Laser Doppler Flowimetry as a Surrogate Endpoint

Further study details as provided by Children's Mercy Hospital Kansas City:

Estimated Enrollment:   50
Study Start Date:   August 2006

Detailed Description:

The specific aim of this study is to validate iontophoresis (with measurement of microvascular blood flow by laser Doppler flowimetry) in a pediatric cohort as a surrogate marker capable of reliably characterizing the normal physiologic response of the cutaneous microvasculature to histamine. In future studies laser Doppler flowimetry ultimately will be used to assess whether microvascular blood flow determined by a previously validated laser Doppler technique can be used as a reliable surrogate endpoint capable of functionally discriminating the effects of polymorphisms in the genes which are quantitatively important for histamine metabolism. The hypothesis to be proven is that histamine iontophoresis with measurement of microvascular blood flow by laser Doppler flowimetry can be used as a reliable marker to characterize the normal microvascular cutaneous response to histamine.

  Eligibility
Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

diagnosed with allergic rhinitis by an attending Pediatrician or Allergist (diagnosis made on clinical grounds or by positive skin test or RAST to environmental allergens, trees, grass, weeds, mold, animal dander, cockroach, dust mite)

-

Exclusion Criteria:

history or evidence of McCune Albright syndrome, immunodeficiency, mastocytosis, receipt of allergy shots, chronic skin disease, liver or kidney disease, cancer, neurological movement disorders, uncontrolled ADHD, evidence of eczema currently or in the past 2 years, history of anaphylaxis or anaphylactic like episode, evidence of pregnancy (by urinary hCG) or lactation, use of antihistamines 10 days prior to skin testing, use of systemic corticosteroids or tricyclic antidepressants 30 days prior to skin testing, presence of condition that would cause difficulty in adherence with study procedure.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362999

Contacts
Contact: Bridgette L Jones, MD     816-234-3097     bljones@cmh.edu    
Contact: Azure Guidry     816-855-1925    

Locations
United States, Missouri
Children's Mercy Hospital     Not yet recruiting
      Kansas City, Missouri, United States, 64108
      Principal Investigator: Bridgette L Jones, MD            
Children's Mercy Hospital     Not yet recruiting
      Kansas City, Missouri, United States, 64108

Sponsors and Collaborators
Children's Mercy Hospital Kansas City

Investigators
Principal Investigator:     Bridgette L Jones, MD     Children's Mercy Hospital    
Study Chair:     Greg Kearns, PharmD     Children's Mercy Hospital    
Study Director:     Kathleeen Neville, MD     Children's Mercy Hospital    
  More Information


Study ID Numbers:   0603042
First Received:   August 10, 2006
Last Updated:   August 10, 2006
ClinicalTrials.gov Identifier:   NCT00362999
Health Authority:   United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Allergic  
Rhinitis  
Pharmacogenetics  
Histamine  

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Histamine phosphate
Rhinitis
Histamine

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine Agonists
Physiological Effects of Drugs
Histamine Agents
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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