Characterization of the Role of Histamine in Children With Asthma
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|ClinicalTrials.gov Identifier: NCT01392859|
Recruitment Status : Unknown
Verified July 2011 by Children's Mercy Hospital Kansas City.
Recruitment status was: Recruiting
First Posted : July 13, 2011
Last Update Posted : July 13, 2011
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. The investigators will also investigate the role of genetic variation in the observed differences in HILD between the two groups. The second aim will characterize the pharmacodynamic response to antihistamines via HILD in children with an exaggerated histamine response compared to children with a low histamine response. This aim will be accomplished through conduct of a randomized, double-blind, placebo-controlled cross-over trial of levocetirizine (LCT) in the two groups (high histamine and low histamine) and observing the difference in antihistamine pharmacodynamics in the two groups. The investigators will also investigate the effect of pharmacokinetic variation and genetic variation in the histamine pathway on the observed pharmacodynamic drug response.
|Condition or disease||Intervention/treatment||Phase|
|Asthma Allergic Asthma Non-allergic Asthma||Drug: levocetirizine Other: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||204 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Characterization of the Role of Histamine in Children With Asthma|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||May 2016|
5mg liquid or capsule, daily, five days
Other Name: Xyzal®
|Placebo Comparator: placebo||
placebo will be given in liquid or capsule form to match levocetirizine, for five days
- To characterize the relative contribution of histamine in children with asthma [ Time Frame: one year ]The investigators will compare the response to histamine via histamine iontophoresis with laser doppler monitoring (measured in flux units)between subjects with allergic asthma compared to subjects with non-allergic asthma.
- Characterization of the role of histamine in children with a defined phenotype of allergic asthma [ Time Frame: 2 months ]The investigators will compare the pharmacodynamic response to treatement with antihistamines via histamine iontophoresis with laser doppler (HILD) monitoring in children with allergic asthma. We evaluate differences in response to HILD (measured in flux units) between children with a "high histamine" phenotype compared to children with a "low histamine" phenotype as determined in the primary outcome measure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392859
|Contact: Bridgette Jones, MD||(816)firstname.lastname@example.org|
|Contact: Casey Martiznez, BPS||(816)email@example.com|
|United States, Missouri|
|Children's Mercy Hospital and Clinics||Recruiting|
|Kansas City, Missouri, United States, 64131|
|Contact: Jones 816-234-3000|
|Principal Investigator: Bridgette L. Jones, MD|
|Principal Investigator:||Bridgette L. Jones, MD||Children's Mercy Hospital and Clinics|