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Trial record 57 of 66 for:    Levocetirizine

Characterization of the Role of Histamine in Children With Asthma

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ClinicalTrials.gov Identifier: NCT01392859
Recruitment Status : Unknown
Verified July 2011 by Children's Mercy Hospital Kansas City.
Recruitment status was:  Recruiting
First Posted : July 13, 2011
Last Update Posted : July 13, 2011
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City

Brief Summary:

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 or disease Intervention/treatment Phase
Asthma Allergic Asthma Non-allergic Asthma Drug: levocetirizine Other: placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Characterization of the Role of Histamine in Children With Asthma
Study Start Date : June 2011
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. To characterize the relative contribution of histamine in children with asthma [ Time Frame: one year ]
    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 :
  1. Characterization of the role of histamine in children with a defined phenotype of allergic asthma [ Time Frame: 2 months ]
    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.



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: July 13, 2011
Last Verified: July 2011

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