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

Northwell Health

Status

Completed

Conditions

Inflammation

Asthma

Obesity

Treatments

Drug: Montelukast

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01329939

10-029B

Details and patient eligibility

About

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

26 participants in 4 patient groups, including a placebo group

Obese atopic asthmatics, montelukast

Experimental group

Description:

Obese/overweight (BMI 85%ile or above for children and \> 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive montelukast in a double blinded fashion.

Treatment:

Drug: Montelukast

Lean atopic asthmatics, placebo

Placebo Comparator group

Description:

Normal weight (BMI less than 85%ile or above for children and \< 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive placebo in a double blinded fashion.

Treatment:

Drug: Placebo

Lean atopic asthmatics, montelukast

Active Comparator group

Description:

Normal weight (BMI less than 85%ile or above for children and \< 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive montelukast in a double blinded fashion.

Treatment:

Drug: Montelukast

Obese atopic asthmatics, Placebo

Placebo Comparator group

Description:

Obese/overweight (BMI 85%ile or above for children and \> 25 for adults) mild to moderate persistent asthmatics age 7 and above, with environmental allergies who were on daily inhaled corticosteroid treatment and not on montelukast, were randomized to receive placebo in a double blinded fashion.

Treatment:

Drug: Placebo

Trial contacts and locations

1

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