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NCT01392859 · ClinicalTrials.gov registry record · Phase 2

Characterization of the Role of Histamine in Children With Asthma

A Phase 2 study of Asthma and Allergic Asthma, sponsored by Children's Mercy Hospital Kansas City.

Completed
Registry status
Phase 2
Development phase
211
Enrollment target
1
Study location

NCT01392859: Completed Phase 2 study of Asthma and Allergic Asthma, sponsored by Children's Mercy Hospital Kansas City.

NCT01392859 is a Phase 2 study of Asthma and Allergic Asthma that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 211 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01392859, a Phase 2 study of Asthma and Allergic Asthma, has completed, sponsored by Children's Mercy Hospital Kansas City.

COMPLETED
Registry status
Phase 2
Development phase
211 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Interventions

  • DRUG Levocetirizine 0.5 Mg/mL Oral Solution

Study Locations (1)

Missouri

  • Children's Mercy Hospital and Clinics - Kansas City

Trial Details

FieldValue
Enrollment Target 211 participants
Start Date 2011-06
Est. Completion 2015-03-29
Phase Phase 2

What the finished NCT01392859 record still lists

NCT01392859 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (87% lower).

The record links to 3 conditions, with Asthma appearing as the primary indexed condition, and to 1 intervention - of which Levocetirizine 0.5 Mg/mL Oral Solution is the first listed.

NCT01392859 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT01392859 about?

NCT01392859 is a clinical study titled "Characterization of the Role of Histamine in Children With Asthma". 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 t...

What is the current status of trial NCT01392859?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 211 participants. The study started on 2011-06. Estimated completion is 2015-03-29.

What conditions does trial NCT01392859 study?

This clinical trial studies the following conditions: Asthma, Allergic Asthma, Non-allergic Asthma.

What interventions are being tested in trial NCT01392859?

The interventions under investigation include: Levocetirizine 0.5 Mg/mL Oral Solution (DRUG).

Who is sponsoring clinical trial NCT01392859?

This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01392859 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Asthma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01392859's enrollment target sits among peer trials

211 155th of 374 higher than 219 of 374 other Asthma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01392859, the US trial registry maintained by the National Library of Medicine. NCT01392859 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.