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Characterization of the Role of Histamine in Children With Asthma

Primary Purpose

Asthma, Allergic Asthma, Non-allergic Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Levocetirizine 0.5 Mg/mL Oral Solution
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asthma

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Mercy Hospital and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Initial Treatment: Levocetirizine(LCT)

Initial Treatment: Placebo

Arm Description

Group 1 will begin with active Levocetirizine(LCT) 0.5 mg/ml oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and placebo will be provided for 5-8 days.

Group 2 will begin with placebo oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and active Levocetirizine(LCT) 0.5 mg/ml will be provided for 5-8 days.

Outcomes

Primary Outcome Measures

Characterize Contribution of Histamine in Children With Asthma
The investigators will compare the response to histamine via histamine iontophoresis with laser doppler monitoring (measured in flux units on a continuous scale)between subjects with allergic asthma compared to subjects with non-allergic asthma.

Secondary Outcome Measures

Full Information

First Posted
July 6, 2011
Last Updated
August 26, 2021
Sponsor
Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT01392859
Brief Title
Characterization of the Role of Histamine in Children With Asthma
Official Title
Characterization of the Role of Histamine in Children With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
March 29, 2015 (Actual)
Study Completion Date
March 29, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Mercy Hospital Kansas City

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Allergic Asthma, Non-allergic Asthma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Initial Treatment: Levocetirizine(LCT)
Arm Type
Experimental
Arm Description
Group 1 will begin with active Levocetirizine(LCT) 0.5 mg/ml oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and placebo will be provided for 5-8 days.
Arm Title
Initial Treatment: Placebo
Arm Type
Experimental
Arm Description
Group 2 will begin with placebo oral solution for 5-8 days. This arm will then undergo a 3-7 day washout period at which point crossover will occur and active Levocetirizine(LCT) 0.5 mg/ml will be provided for 5-8 days.
Intervention Type
Drug
Intervention Name(s)
Levocetirizine 0.5 Mg/mL Oral Solution
Intervention Description
Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.
Primary Outcome Measure Information:
Title
Characterize Contribution of Histamine in Children With Asthma
Description
The investigators will compare the response to histamine via histamine iontophoresis with laser doppler monitoring (measured in flux units on a continuous scale)between subjects with allergic asthma compared to subjects with non-allergic asthma.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bridgette L. Jones, MD
Organizational Affiliation
Children's Mercy Hospital and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Characterization of the Role of Histamine in Children With Asthma

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