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The Effect of Montelukast on Asthma Control in Overweight/Obese Early-Onset Asthmatics

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City:   Great Neck
State:   New York
Zip Code:   11023
Conditions:   Asthma - Obesity - Inflammation
Purpose:   Background: In recent years, the prevalence of both asthma and obesity has risen dramatically among children and adolescents in the United States. Given the concurrent rise in the two epidemics, there may be an underlying link. Obesity contributes to asthma severity and control, and may play a role in its underlying cause. Obesity is associated with a state of heightened inflammation that may lead to an increase asthma symptoms and severity. Obese adult patients treated with montelukast, an anti-inflammatory agent, seemed to have better asthma control than those treated with other standard asthma medications. The use of montelukast in obese children and adolescents has not been specifically studied. Hypotheses and Specific Aims: The use of montelukast will improve asthma symptoms and objective markers of asthma to a greater degree in obese, as opposed to non-obese children and adolescents. The investigators would like to determine if the use of montelukast will improve objective asthma scores, pulmonary function, markers of inflammation and medication use to a greater degree in obese as opposed to non-obese children/adolescents. Potential Impact: Given the growing epidemic of obesity-associated asthma in the U.S., a tailored approach focused on obese asthmatic children may help reduce the burden of this disease, health care costs and potential long-term complications as these children enter adulthood. Furthermore, this study may help clarify the underlying mechanisms that link asthma and obesity. Although this proposal is focused on one medication, it provides an example of how certain medications may have differential efficacy in the obese asthmatic.
Study Summary:  
Criteria:   Inclusion Criteria: - mild to moderate persistent asthma based on 2007 NIH Asthma Guidelines - age 7-17 years old Exclusion Criteria: - present smoking or smoking history - other significant pulmonary or cardiac condition - recent (within the past three months) use of montelukast - on allergen immunotherapy - on omalizumab - pregnancy
NCT ID:   NCT01329939
Primary Contact:   Principal Investigator
Sherry Farzan, MD
North Shore Long Island Jewish Health System

Sherry Farzan, MD
Phone: 5166225070
Email: sfarzan@nshs.edu
Backup Contact:   N/A
Location Contact:   Great Neck, New York 11023
United States

Sherry Farzan, MD
Phone: 516-622-5070
Email: sfarzan@nshs.edu

Site Status: Recruiting

Data Source:   ClinicalTrials.gov
Date Processed:   April 16, 2014
Modifications to this listing:   Only selected fields are shown, please use the link below to view all information about this clinical trial.
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