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

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ClinicalTrials.gov Identifier: NCT00362999
Recruitment Status : Unknown
Verified July 2011 by Children's Mercy Hospital Kansas City.
Recruitment status was:  Recruiting
First Posted : August 15, 2006
Last Update Posted : July 8, 2011
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City

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

Condition or disease
Allergic Rhinitis

Detailed Description:
The specific aim of this study is to validate iontophoresis (with measurement of microvascular blood flow by laser Doppler flowmetry) 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 flowmetry 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 flowmetry can be used as a reliable marker to characterize the normal microvascular cutaneous response to histamine.

Study Type : Observational
Estimated Enrollment : 70 participants
Time Perspective: Prospective
Official Title: Histamine Pharmacodynamics in Patients With Allergic Rhinitis: Validation of Laser Doppler Flowmetry as a Surrogate Endpoint
Study Start Date : August 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. comparison of histamine iontophoresis laser doppler monitoring with epicutaneous histamine testing in measuring the microvasculature response to histamine [ Time Frame: one time point ]

Secondary Outcome Measures :
  1. intra-individual variability of histamine iontophoresis with laser doppler monitoring [ Time Frame: at least 6 months ]

    Determine the intra-individual variability of histamine iontophoresis with laser doppler flowimetry.

    Twenty subjects will be asked to return for 2 more visits for histamine iontophoresis with laser doppler flowimetry and the intra-individual variability of the measurement will be determined.



Biospecimen Retention:   Samples With DNA
blood


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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients with allergic rhinitis
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.


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 ClinicalTrials.gov identifier (NCT number): NCT00362999


Contacts
Contact: Bridgette L Jones, MD 816-234-3097 bljones@cmh.edu
Contact: Ann Harris 816-234-3059

Locations
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Principal Investigator: Bridgette L Jones, MD         
Children's Mercy Hospital 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

Responsible Party: Bridgette L. Jones, MD, Childrnen's Mercy Hospitals and Clinics
ClinicalTrials.gov Identifier: NCT00362999     History of Changes
Other Study ID Numbers: 0603042
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: July 8, 2011
Last Verified: July 2011

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

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs