Clinical trial NCT01329939
Conditions: Asthma Obesity Inflammation
Keywords: Asthma Obesity Pediatric Inflammation Leukotriene Montelukast
Sponsor: Northwell Health
Start date: 2011-04-01; Completion date: 2014-09-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:

Arms: arm 1: 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. arm 2: 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. arm 3: 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. arm 4: 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.
Interventions: intervention 1: Montelukast intervention 2: Placebo intervention 3: Montelukast intervention 4: Placebo
Intervention descriptions: intervention 1: Age-dependent dose, nightly, 24 weeks intervention 2: Age-dependent dose, nightly, 24 weeks intervention 3: Age-dependent dose, nightly, 24 weeks intervention 4: Age-dependent dose, nightly, 24 weeks

Protocol documents: