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Sponsored by: |
Children's Mercy Hospital Kansas City |
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Information provided by: | Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT00362999 |
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 |
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Allergic Rhinitis |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Histamine Pharmacodynamics in Patients With Allergic Rhinitis: Validation of Laser Doppler Flowmetry as a Surrogate Endpoint |
Estimated Enrollment: | 50 |
Study Start Date: | August 2006 |
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.
Ages Eligible for Study: | 7 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Pediatric patients with allergic rhinitis
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)
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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.
Contact: Bridgette L Jones, MD | 816-234-3097 | bljones@cmh.edu |
Contact: Ann Harris | 816-234-3059 |
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 |
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: | Childrnen's Mercy Hospitals and Clinics ( Bridgette L. Jones, MD ) |
Study ID Numbers: | 0603042 |
Study First Received: | August 10, 2006 |
Last Updated: | January 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00362999 History of Changes |
Health Authority: | United States: Institutional Review Board |
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