Characterization of the Role of Histamine in Children With Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by Children's Mercy Hospital Kansas City
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT01392859
First received: July 6, 2011
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

Asthma, a chronic disease which produces significant morbidity and mortality in children, is a significant health problem to a large segment of society. Despite considerable advances in the diagnosis and treatment of asthma over the past several years, a sizeable portion of patients do not respond to the "core" treatments. The investigators are now learning that the underlying pathophysiology of disease is different among patients with asthma therefore; treatments which are beneficial in some patient groups may be not achieve affect in other groups.

Antihistamines have been studied in the past for the treatment of asthma. These studies have shown that there may be a beneficial effect of antihistamines in patients with allergic asthma where histamine likely plays a large role in disease and treatment response. However, there is not enough evidence to include these drugs in the standard treatment of asthma.

The investigators hypothesize that histamine plays a definable, significant role in disease pathogenesis and treatment response in children with allergic asthma. The investigators plan to test this overall hypothesis through two specific aims. The first aim will characterize the relative contribution of histamine in allergic vs. non-allergic asthma. This aim will be accomplished by comparison of the microvasculature response to histamine in children with allergic asthma and children with non-allergic asthma, measured by histamine iontophoresis with laser Doppler (HILD) monitoring, to determine potential phenotype-associated differences in the pharmacodynamic response to histamine. The investigators will also investigate the role of genetic variation in the observed differences in HILD between the two groups. The second aim will characterize the pharmacodynamic response to antihistamines via HILD in children with an exaggerated histamine response compared to children with a low histamine response. This aim will be accomplished through conduct of a randomized, double-blind, placebo-controlled cross-over trial of levocetirizine (LCT) in the two groups (high histamine and low histamine) and observing the difference in antihistamine pharmacodynamics in the two groups. The investigators will also investigate the effect of pharmacokinetic variation and genetic variation in the histamine pathway on the observed pharmacodynamic drug response.


Condition Intervention
Asthma
Allergic Asthma
Non-allergic Asthma
Drug: levocetirizine
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Characterization of the Role of Histamine in Children With Asthma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To characterize the relative contribution of histamine in children with asthma [ Time Frame: one year ] [ Designated as safety issue: No ]
    The investigators will compare the response to histamine via histamine iontophoresis with laser doppler monitoring (measured in flux units)between subjects with allergic asthma compared to subjects with non-allergic asthma.


Secondary Outcome Measures:
  • Characterization of the role of histamine in children with a defined phenotype of allergic asthma [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The investigators will compare the pharmacodynamic response to treatement with antihistamines via histamine iontophoresis with laser doppler (HILD) monitoring in children with allergic asthma. We evaluate differences in response to HILD (measured in flux units) between children with a "high histamine" phenotype compared to children with a "low histamine" phenotype as determined in the primary outcome measure.


Estimated Enrollment: 204
Study Start Date: June 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: antihistamine Drug: levocetirizine
5mg liquid or capsule, daily, five days
Other Name: Xyzal®
Placebo Comparator: placebo Other: placebo
placebo will be given in liquid or capsule form to match levocetirizine, for five days

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children age 7-17 years old
  • with the diagnosis of allergic asthma or non-allergic asthma (n=102

Exclusion Criteria:

  • history of immunodeficiency, mastocytosis
  • chronic abnormal conditions of the skin, liver or kidney
  • neoplastic disease
  • movement or neurologic disorders
  • active eczema on the forearms at the time of study
  • history of a previous anaphylactic episode
  • evidence of pregnancy (by urinary hCG) or lactation at the time of the study
  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: NCT01392859

Contacts
Contact: Bridgette Jones, MD (816)234-3000 bljones@cmh.edu
Contact: Casey Martiznez, BPS (816)234-3059 clmartinez@cmh.edu

Locations
United States, Missouri
Children's Mercy Hospital and Clinics Recruiting
Kansas City, Missouri, United States, 64131
Contact: Jones    816-234-3000      
Principal Investigator: Bridgette L. Jones, MD         
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Bridgette L. Jones, MD Children's Mercy Hospital and Clinics
  More Information

No publications provided

Responsible Party: Bridgette L. Jones, MD/Assistant Professor of Pediatrics, Children's Mercy Hospital and Clinics
ClinicalTrials.gov Identifier: NCT01392859     History of Changes
Other Study ID Numbers: 105783-01
Study First Received: July 6, 2011
Last Updated: July 12, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Levocetirizine
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014