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

July 2, 2024 updated by: Bridgette Jones, Children's Mercy Hospital Kansas City

Histamine Pharmacodynamics in Patients With Allergic Rhinitis: Validation of Laser Doppler Flowmetry as a Surrogate Endpoint

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 Overview

Status

Completed

Conditions

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

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients with allergic rhinitis

Description

Inclusion Criteria:

-Established diagnosis of allergic rhinitis and/or allergic conjunctivitis, and/or allergic asthma either clinically (by presence of rhinitis and/or conjunctivitis with or without associated wheezing) and/or with a positive RAST/skin test to the following allergens: trees, grass, weeds, molds, cat, dog, dust mites and/or cockroach)

Exclusion Criteria:

  • Previous history or laboratory evidence of McCune Albright syndrome, immunodeficiency, mastocytosis, receipt of immunomodulatory treatment, chronic conditions associated with abnormalities of the integument, hepatic or renal compromise, neoplastic disease, movement or neurologic disorders and uncontrolled ADHD
  • Active atopic dermatitis at the site of the skin prick test or site where histamine iontophoresis will be performed, i.e. active atopic dermatitis on anterior forearms
  • History of anaphylaxis or anaphylactic like episode
  • Evidence of pregnancy (by urinary hCG) or lactation
  • Use of drugs (within a specified time period) of agents capable of altering the response to histamine provocation (e.g., antihistamines, systemic corticosteroids, tricyclic antidepressants)
  • Presence of any condition that, in the opinion of the investigator, would produce difficulty with adherence to study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
comparison of histamine iontophoresis laser doppler monitoring with epicutaneous histamine testing in measuring the microvasculature response to histamine
Time Frame: one time point
one time point

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at least 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Bridgette L Jones, MD, Children's Mercy Hospital Kansas City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2006

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

August 10, 2006

First Submitted That Met QC Criteria

August 10, 2006

First Posted (Estimated)

August 15, 2006

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11120477

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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