CClinicalTrials.gg
CompletedNCT00362999Updated Jul 3, 2024

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

An observational study in Allergic Rhinitis, sponsored by Children's Mercy Hospital Kansas City. Completed at 1 site in United States. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Children's Mercy Hospital Kansas City · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
74
Ages
7 Years to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Allergic Rhinitis

Keywords

  • Allergic
  • Rhinitis
  • Pharmacogenetics
  • Histamine
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 74 is below the median of 141 across 172 observational studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Children's Mercy Hospital Kansas City is the lead sponsor of 209 studies on the registry; 22 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 14 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric patients with allergic rhinitis

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

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.
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
74 participants (actual)
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  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 outcomes

  1. intra-individual variability of histamine iontophoresis with laser doppler monitoring

    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.

    Time frame: at least 6 months

07

Study locations

1 site
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00362999
Lead sponsor
Children's Mercy Hospital Kansas City
Responsible party
Bridgette Jones (Associate Professor of Pediatrics, MD, MSCR, Children's Mercy Hospital Kansas City) — Principal investigator
First posted
Aug 15, 2006
Start date
Aug 2006
Primary completion
Jul 2024
Completion
Jul 2024
Last update
Jul 3, 2024

Study contacts

Bridgette L Jones, MD
principal investigator · Children's Mercy Hospital Kansas City

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion