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

NCT01329939 | Completed Results

• 1 other identifier: 10-029B
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma; Obesity; Inflammation

Keywords

Asthma; Obesity; Pediatric; Inflammation; Leukotriene; Montelukast

Outcome Measures

Primary Outcomes (1)

• Asthma Control Test (ACT) Scores

  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.

  24 weeks

Secondary Outcomes (7)

• Spirometric Measures

  24 weeks

• Serum Leptin Levels

  24 weeks

• Urinary Leukotriene E4 (LTE4) Levels

  24 weeks

• Exhaled Nitric Oxide Measurement

  24 weeks

• Beclomethasone Equivalents

  24 weeks

Study Arms (4)

Obese atopic asthmatics, montelukast

EXPERIMENTAL

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

Lean atopic asthmatics, placebo

PLACEBO COMPARATOR

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

Lean atopic asthmatics, montelukast

ACTIVE COMPARATOR

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

Obese atopic asthmatics, Placebo

PLACEBO COMPARATOR

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

Interventions

Montelukast DRUG

Age-dependent dose, nightly, 24 weeks

Also known as: Singulair

Lean atopic asthmatics, montelukast

Placebo DRUG

Age-dependent dose, nightly, 24 weeks

Lean atopic asthmatics, placebo

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• mild to moderate persistent asthma based on 2007 NIH Asthma Guidelines
• age 7-17 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• Thrasher Research Fund: collaborator
• Merck Sharp & Dohme LLC: collaborator
• New York State Department of Health: collaborator

Study Sites (1)

North Shore-Long Island Jewish Health System, Division of Allergy/Immunology

Great Neck, New York, 11023, United States

Location

Related Publications (1)

• Farzan S, Khan S, Elera C, Tsang J, Akerman M, DeVoti J. Effectiveness of montelukast in overweight and obese atopic asthmatics. Ann Allergy Asthma Immunol. 2017 Aug;119(2):189-190. doi: 10.1016/j.anai.2017.05.024. Epub 2017 Jun 28. No abstract available.

  PMID: 28668546 DERIVED

MeSH Terms

Conditions

Asthma; Obesity; Inflammation

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Results Point of Contact

• Title: Dr. Sherry Farzan, Attending Physician, Assistant Professor of Medicine and Pediatrics
• Organization: North Shore - Long Island Jewish Health System; Hofstra North Shore-LIJ School of Medicine

sfarzan@nshs.edu

5166225070

Study Officials

• Sherry Farzan, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: April 6, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 7, 2016
• Results First Posted: April 7, 2016

Record last verified: 2016-03

Locations

US (1)