Obesity Clinical Trial
Official title:
The Effect of Montelukast on Asthma Control in Overweight/Obese Early-Onset Asthmatics
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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