The Effect of Montelukast on Asthma Control in Obese Asthmatic Children and Adolescents
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Asthma Obesity Inflammation |
Drug: Montelukast Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Effect of Montelukast on Asthma Control in Obese Asthmatic Children and Adolescents |
- Change in Asthma Control Test (ACT) Scores [ Time Frame: 0, 4, 8, 12, 16, 20, 24 weeks ] [ Designated as safety issue: No ]The ACT is a validated questionaire-based tool designed to assess asthma control.
- Change in spirometric measures [ Time Frame: 0, 4, 12, 24 weeks ] [ Designated as safety issue: No ]Breathing maneuvers which help to measure obstruction of airways.
- Change in serum leptin levels [ Time Frame: 0, 12, 24 weeks ] [ Designated as safety issue: No ]Leptin levels, measured through blood, mediate appetite and are elaborated by adipose tissue. In addition, leptin plays a role in producing an inflammatory state.
- Change in urine leukotriene E4 (LTE4) levels [ Time Frame: 0. 12, 24 months ] [ Designated as safety issue: No ]LTE4 levels, measured in the urine, reflect the degree of inflammation in the asthmatic airway.
| Estimated Enrollment: | 140 |
| Study Start Date: | April 2011 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Obese children and adolescents, montelukast |
Drug: Montelukast
Age-dependent dose, nightly, 24 weeks
|
| Placebo Comparator: Normal-weight children and adolescents, placebo |
Drug: Placebo
Age-dependent dose, nightly, 24 weeks
|
| Active Comparator: Normal weight children and adolescents, montelukast |
Drug: Montelukast
Age-dependent dose, nightly, 24 weeks
|
| Obese children and adolescents, Placebo |
Drug: Placebo
Age-dependent dose, nightly, 24 weeks
|
Eligibility| Ages Eligible for Study: | 7 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Sherry Farzan, MD | 5166225070 | sfarzan@nshs.edu |
| United States, New York | |
| North Shore-Long Island Jewish Health System, Division of Allergy/Immunology | Recruiting |
| Great Neck, New York, United States, 11023 | |
| Contact: Sherry Farzan, MD 516-622-5070 sfarzan@nshs.edu | |
| Principal Investigator: Sherry Farzan, MD | |
| Principal Investigator: | Sherry Farzan, MD | North Shore Long Island Jewish Health System |
More Information
No publications provided
| Responsible Party: | Sherry Farzan Kashani, Attending, North Shore Long Island Jewish Health System |
| ClinicalTrials.gov Identifier: | NCT01329939 History of Changes |
| Other Study ID Numbers: | 10-029B |
| Study First Received: | March 23, 2011 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by North Shore Long Island Jewish Health System:
|
Asthma Obesity Pediatric |
Inflammation Leukotriene Montelukast |
Additional relevant MeSH terms:
|
Asthma Inflammation Obesity Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pathologic Processes Overnutrition |
Nutrition Disorders Overweight Body Weight Signs and Symptoms Montelukast Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013