Characterization of the Role of Histamine in Children With Asthma

NCT01392859 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 105783-01
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Study Arms (2)

Initial Treatment: Levocetirizine(LCT)

EXPERIMENTAL

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.

Drug: Levocetirizine 0.5 Mg/mL Oral Solution

Initial Treatment: Placebo

EXPERIMENTAL

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.

Drug: Levocetirizine 0.5 Mg/mL Oral Solution

Interventions

Levocetirizine 0.5 Mg/mL Oral Solution 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: Levocetirizine(LCT); Initial Treatment: Placebo

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64131, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

levocetirizine; Solutions

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Bridgette Jones
• Organization: Children's Mercy Hospital

bljones@cmh.edu

816-302-3811

Study Officials

• Bridgette L. Jones, MD

  Children's Mercy Hospital and Clinics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 13, 2011
• Study Start: June 1, 2011
• Primary Completion: March 29, 2015
• Study Completion: March 29, 2015
• Last Updated: August 30, 2021
• Results First Posted: August 30, 2021

Record last verified: 2021-08

Locations

US (1)