Characterization of the Role of Histamine in Children With Asthma

NCT ID: NCT01392859

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2015-03-29

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.

Conditions

Asthma; Allergic Asthma; Non-allergic Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Initial Treatment: Levocetirizine(LCT)

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 Type: EXPERIMENTAL

Levocetirizine 0.5 Mg/mL Oral Solution

Intervention Type: DRUG

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.

Initial Treatment: Placebo

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.

Group Type: EXPERIMENTAL

Levocetirizine 0.5 Mg/mL Oral Solution

Intervention Type: DRUG

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.

Interventions

Levocetirizine 0.5 Mg/mL Oral Solution

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bridgette L. Jones, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital and Clinics

Locations

Children's Mercy Hospital and Clinics

Kansas City, Missouri, United States

Countries

United States

Other Identifiers

105783-01

Identifier Type: -

Identifier Source: org_study_id