CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 211 enrolled
Drug / intervention
Levocetirizine 0.5 Mg/mL Oral Solutiondrug
Likely dose
Levocetirizine 0.5 Mg/mL Oral Solutionfrom record
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Search/NCT01392859
NCT01392859Phase 3Completed

Characterization of the Role of Histamine in Children With Asthma

Children's Mercy Hospital Kansas City·interventional·Posted Jul 13, 2011·Updated Aug 30, 2021

In Brief

A Phase 3 clinical trial evaluating Levocetirizine 0.5 Mg/mL Oral Solution for Asthma and 2 related conditions. Completed, enrolled 211 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 13, 2011
Enrollment StartJun 1, 2011
Primary CompletionMar 29, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.0 years ago

Interventions

Levocetirizine 0.5 Mg/mL Oral Solutiondrug

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.