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

Not Applicable

Completed

Conditions: Asthma
Inflammation
Obesity

Interventions: Drug: Placebo
Drug: Montelukast

Registration Number: NCT01329939

Lead Sponsor: Northwell Health

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: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 26

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese atopic asthmatics, Placebo	Placebo	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.
Lean atopic asthmatics, placebo	Placebo	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.
Obese atopic asthmatics, montelukast	Montelukast	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.
Lean atopic asthmatics, montelukast	Montelukast	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.

Primary Outcome Measures

Name	Time	Method
Asthma Control Test (ACT) Scores	24 weeks	The ACT is a validated questionaire-based tool designed to assess asthma control. Scale range for 7-11 year olds is 0-27 and for 12 years and older 5-25, with lower scores indicating poorer asthma control for all ages. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.

Secondary Outcome Measures

Name	Time	Method
Exhaled Nitric Oxide Measurement	24 weeks	A non-invasive measure of eosinophilic airway inflammation. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.
Beclomethasone Equivalents	24 weeks	The total daily dose of inhaled corticosteroids in beclomethasone equivalents. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.
Serum Leptin Levels	24 weeks	Leptin levels, measured through blood, mediate appetite and are elaborated by adipose tissue. Levels correlate positively with body fat percentage. In addition, leptin plays a role in producing an inflammatory state. Adiponectin, which is also secreted by adipose tissue, regulates metabolism, however its levels are inversely correlated with body fat percentage.
Urinary Creatinine (Cr) Levels	24 weeks	Creatinine, measured in the urine, reflects how well the kidneys are working, and provide a standard to which one can compare other metabolites in the urine. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.
Spirometric Measures	24 weeks	Breathing maneuvers which help to measure obstruction of airways. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.
Urinary Leukotriene E4 (LTE4) Levels	24 weeks	LTE4 levels, measured in the urine, reflect the degree of inflammation in the asthmatic airway. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.
Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio	24 weeks	The ratio of urinary LTE4 to Cr provides a standardization of the LTE4 level based on the patients weight and muscle mass, therefore normalizing it across the different subjects. We did not perform percent change from baseline since in a randomized clinical trial, where the groups are comparable at baseline, we can use only the post-treatment (week 24) data in the analysis.