Characterization of the Role of Histamine in Children With Asthma

Asthma Clinical Trial

Official title:

Characterization of the Role of Histamine in Children With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392859
• Other study ID #: 105783-01
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2011
• Est. completion date: March 29, 2015

Study information

• Verified date: August 2021
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: March 29, 2015
• Est. primary completion date: March 29, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma
• Non-allergic Asthma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Children's Mercy Hospital and Clinics	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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