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

Summary

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.

Conditions

• Asthma
• Obesity
• Inflammation

Interventions

DRUG

Montelukast

Age-dependent dose, nightly, 24 weeks

DRUG

Placebo

Age-dependent dose, nightly, 24 weeks

DRUG

Montelukast

Age-dependent dose, nightly, 24 weeks

DRUG

Placebo

Age-dependent dose, nightly, 24 weeks

Sponsors & Collaborators

• Thrasher Research Fund

  collaborator OTHER

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• New York State Department of Health

  collaborator OTHER_GOV

• Northwell Health

  lead OTHER

Principal Investigators

• Sherry Farzan, MD · Northwell Health

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2014-09-30

Completion

2014-09-30

Countries

• United States

Study Locations