The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics

Completed · Not applicable · Has a placebo group

Conditions studied: Asthma, Obesity, Inflammation

In brief

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.

Key facts

Study ID

NCT01329939

Run by

Northwell Health

People needed

26

Starts

2011-04-01

Expected to finish

2014-09-01

Last updated by the study team

2016-04-07

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• mild to moderate persistent asthma based on 2007 NIH Asthma Guidelines
• age 7-17 years old

You may not qualify if…

• 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

Where it is running

• North Shore-Long Island Jewish Health System, Division of Allergy/Immunology — Great Neck, New York, United States

Full record on ClinicalTrials.gov

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