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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329939
• Other study ID #: 10-029B
• Status: Completed
• Phase: N/A
• First received: March 23, 2011
• Last updated: April 15, 2015
• Start date: April 2011
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Inflammation
• Obesity

Intervention

Drug:
• Montelukast
Age-dependent dose, nightly, 24 weeks
• Placebo
Age-dependent dose, nightly, 24 weeks
• Montelukast
Age-dependent dose, nightly, 24 weeks
• Placebo
Age-dependent dose, nightly, 24 weeks

Locations

Country	Name	City	State
United States	North Shore-Long Island Jewish Health System, Division of Allergy/Immunology	Great Neck	New York

Sponsors (4)

Lead Sponsor	Collaborator
Northwell Health	Empire Clinical Research Investigator Program, Merck Sharp & Dohme Corp., Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Asthma Control Test (ACT) Scores	The ACT is a validated questionaire-based tool designed to assess asthma control.	0, 4, 8, 12, 16, 20, 24 weeks	No
Secondary	Change in spirometric measures	Breathing maneuvers which help to measure obstruction of airways.	0, 4, 12, 24 weeks	No
Secondary	Change in serum leptin levels	Leptin levels, measured through blood, mediate appetite and are elaborated by adipose tissue. In addition, leptin plays a role in producing an inflammatory state.	0, 12, 24 weeks	No
Secondary	Change in urine leukotriene E4 (LTE4) levels	LTE4 levels, measured in the urine, reflect the degree of inflammation in the asthmatic airway.	0. 12, 24 months	No