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

This study has been completed.
Sponsor:
Collaborators:
Thrasher Research Fund
Merck Sharp & Dohme Corp.
New York State Department of Health
Information provided by (Responsible Party):
Sherry Farzan Kashani, Northwell Health
ClinicalTrials.gov Identifier:
NCT01329939
First received: March 23, 2011
Last updated: March 9, 2016
Last verified: March 2016
  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 Atopic Asthmatics

Resource links provided by NLM:


Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • Asthma Control Test (ACT) Scores [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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:
  • Spirometric Measures [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Serum Leptin Levels [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 Leukotriene E4 (LTE4) Levels [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Exhaled Nitric Oxide Measurement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Urinary Creatinine (Cr) Levels [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 26
Study Start Date: April 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Obese atopic asthmatics, 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.
Drug: Montelukast
Age-dependent dose, nightly, 24 weeks
Other Name: Singulair
Placebo Comparator: Lean atopic asthmatics, 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.
Drug: Placebo
Age-dependent dose, nightly, 24 weeks
Active Comparator: Lean atopic asthmatics, 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.
Drug: Montelukast
Age-dependent dose, nightly, 24 weeks
Other Name: Singulair
Placebo Comparator: Obese atopic asthmatics, 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.
Drug: Placebo
Age-dependent dose, nightly, 24 weeks

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years   (Child)
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

Locations
United States, New York
North Shore-Long Island Jewish Health System, Division of Allergy/Immunology
Great Neck, New York, United States, 11023
Sponsors and Collaborators
Northwell Health
Thrasher Research Fund
Merck Sharp & Dohme Corp.
New York State Department of Health
Investigators
Principal Investigator: Sherry Farzan, MD Northwell Health
  More Information

Responsible Party: Sherry Farzan Kashani, Attending, Northwell Health
ClinicalTrials.gov Identifier: NCT01329939     History of Changes
Other Study ID Numbers: 10-029B 
Study First Received: March 23, 2011
Results First Received: December 30, 2015
Last Updated: March 9, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Northwell Health:
Asthma
Obesity
Pediatric
Inflammation
Leukotriene
Montelukast

Additional relevant MeSH terms:
Asthma
Inflammation
Overweight
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Body Weight
Signs and Symptoms
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016