Clinical trial NCT01329939: The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics
Official title: The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Obesity
Inflammation
Keywords: Asthma
Obesity
Pediatric
Inflammation
Leukotriene
Montelukast
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
name: Merck Sharp & Dohme LLC
name: New York State Department of Health
First posted: 2011-04-06
Enrollment: 26
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Asthma Control Test (ACT) Scores
timeFrame: 24 weeks
Secondary outcomes:
measure: Spirometric Measures
timeFrame: 24 weeks
measure: Serum Leptin Levels
timeFrame: 24 weeks
measure: Urinary Leukotriene E4 (LTE4) Levels
timeFrame: 24 weeks
measure: Exhaled Nitric Oxide Measurement
timeFrame: 24 weeks
measure: Beclomethasone Equivalents
timeFrame: 24 weeks
measure: Urinary Creatinine (Cr) Levels
timeFrame: 24 weeks
measure: Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Great Neck
country: United States
facility: North Shore-Long Island Jewish Health System, Division of Allergy/Immunology
state: New York
Study officials:
affiliation: Northwell Health
name: Sherry Farzan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farzan S, Khan S, Elera C, Tsang J, Akerman M, DeVoti J. Effectiveness of montelukast in overweight and obese atopic asthmatics. Ann Allergy Asthma Immunol. 2017 Aug;119(2):189-190. doi: 10.1016/j.anai.2017.05.024. Epub 2017 Jun 28. No abstract available.