Expired Study
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Great Neck, New York 11023


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.


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


Study is Available At:


Original ID:

10-029B


NCT ID:

NCT01329939


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

The Effect of Montelukast on Asthma Control in Overweight/Obese Early-Onset Asthmatics


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

7 Years


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

North Shore Long Island Jewish Health System


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

16


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sherry Farzan, MD
Principal Investigator
North Shore Long Island Jewish Health System

Study Dates

Start Date:April 2011
Completion Date:September 2014
Completion Type:Actual
Primary Completion Date:September 2014
Primary Completion Type:Actual
Verification Date:April 2015
Last Changed Date:April 15, 2015
First Received Date:March 23, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in urine leukotriene E4 (LTE4) levels
Time Frame:0. 12, 24 months
Safety Issues:False
Description:LTE4 levels, measured in the urine, reflect the degree of inflammation in the asthmatic airway.
Outcome Type:Secondary Outcome
Measure:Change in serum leptin levels
Time Frame:0, 12, 24 weeks
Safety Issues:False
Description:Leptin levels, measured through blood, mediate appetite and are elaborated by adipose tissue. In addition, leptin plays a role in producing an inflammatory state.
Outcome Type:Secondary Outcome
Measure:Change in spirometric measures
Time Frame:0, 4, 12, 24 weeks
Safety Issues:False
Description:Breathing maneuvers which help to measure obstruction of airways.
Outcome Type:Primary Outcome
Measure:Change in Asthma Control Test (ACT) Scores
Time Frame:0, 4, 8, 12, 16, 20, 24 weeks
Safety Issues:False
Description:The ACT is a validated questionaire-based tool designed to assess asthma control.

Study Interventions

Intervention Type:Drug
Name:Placebo
Description:Age-dependent dose, nightly, 24 weeks
Arm Name:Obese children and adolescents, Placebo
Intervention Type:Drug
Name:Montelukast
Description:Age-dependent dose, nightly, 24 weeks
Arm Name:Obese children and adolescents, montelukast
Intervention Type:Drug
Name:Placebo
Description:Age-dependent dose, nightly, 24 weeks
Arm Name:Normal-weight children and adolescents, placebo
Intervention Type:Drug
Name:Montelukast
Description:Age-dependent dose, nightly, 24 weeks
Arm Name:Normal weight children and adolescents, montelukas

Study Arms

Study Arm Type:Other
Arm Name:Obese children and adolescents, Placebo
Study Arm Type:Active Comparator
Arm Name:Normal weight children and adolescents, montelukast
Study Arm Type:Placebo Comparator
Arm Name:Normal-weight children and adolescents, placebo
Study Arm Type:Experimental
Arm Name:Obese children and adolescents, montelukast

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:North Shore Long Island Jewish Health System
Agency Class:Other
Agency Type:Collaborator
Agency Name:Thrasher Research Fund

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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