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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Children's Mercy Hospital Kansas City.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00362999
First received: August 10, 2006
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

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
Allergic Rhinitis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Histamine Pharmacodynamics in Patients With Allergic Rhinitis: Validation of Laser Doppler Flowmetry as a Surrogate Endpoint

Resource links provided by NLM:


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

Primary Outcome Measures:
  • comparison of histamine iontophoresis laser doppler monitoring with epicutaneous histamine testing in measuring the microvasculature response to histamine [ Time Frame: one time point ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • intra-individual variability of histamine iontophoresis with laser doppler monitoring [ Time Frame: at least 6 months ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 70
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 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.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Bridgette L. Jones, MD, Childrnen's Mercy Hospitals and Clinics
ClinicalTrials.gov Identifier: NCT00362999     History of Changes
Other Study ID Numbers: 0603042
Study First Received: August 10, 2006
Last Updated: July 6, 2011
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014