The Effect of Montelukast on Asthma Control in Obese Asthmatic Children and Adolescents

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by North Shore Long Island Jewish Health System
Sponsor:
Collaborators:
Thrasher Research Fund
Merck Sharp & Dohme Corp.
New York State Empire Clinical Research Investigators Program
Information provided by (Responsible Party):
Sherry Farzan Kashani, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01329939
First received: March 23, 2011
Last updated: January 13, 2014
Last verified: January 2014
  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 Overweight/Obese Early-Onset Asthmatics

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: May 2014 (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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329939

Contacts
Contact: Sherry Farzan, MD 5166225070 sfarzan@nshs.edu

Locations
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         
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Thrasher Research Fund
Merck Sharp & Dohme Corp.
New York State Empire Clinical Research Investigators Program
Investigators
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: January 13, 2014
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
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014