In Vivo Assessment of Histamine Pharmacodynamics

Withdrawn before enrolling · Not applicable

Conditions studied: Histamine Biotransformation

In brief

A critical first step to address the "pharmacodynamic information gap" in pediatrics resides with the development of methods capable of accurately measuring the time dependent effects of xenobiotic exposure in a manner sufficient to enable an integrative analysis of drug action which incorporates both pharmacokinetic and pharmacogenetic determinants. The proposed study will evaluate laser Doppler flowimetry, a necessary initial step in developing an "ideal" pharmacodynamic surrogate endpoint that ultimately could be used in infants, children and adolescents to fully characterize the impact of development on the pharmacokinetic (PK) / pharmacodynamic (PD) / pharmacogenetic (PG) determinants of drug effect for agents capable of modulating the cellular response to histamine.

Key facts

Study ID

NCT00809692

Run by

Children's Mercy Hospital Kansas City

People needed

0

Starts

2007-09-01

Expected to finish

2008-09-01

Last updated by the study team

2021-01-07

Who can join

Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between ages of 7 and 18 years
• Diagnosed with allergic disease (i.e., allergic rhinitis, allergic conjunctivitis, allergic asthma)
• Informed consent (Parental permission and subject assent)

You may not qualify if…

• 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
• Evidence of atopic dermatitis within a 2 year period from the time of study
• History of previous anaphylactic or anaphylactoid episode
• Evidence of pregnancy (by urinary hCG) or lactation at the time of study
• Receipt 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.

Where it is running

• Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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