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N/A N=26 Randomized Double-blind Treatment

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

Asthma · Obesity · Inflammation

Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Asthma Control Test (ACT) Scores — 25.00; 20.5; 24.00; 15.75 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Montelukast (Drug); Placebo (Drug)
Age
Pediatric · 7+ yrs
Sex
All
Sponsor
Northwell Health
Primary completion
Sep 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Asthma Control Test (ACT) Scores
25.00; 20.5; 24.00; 15.75
SECONDARY
Spirometric Measures
83.37; 85.31; 97.87; 71.79; 91.01; 88.87
SECONDARY
Serum Leptin Levels
44.35; 4.13; 10.90; 34.88; 10.27; 11.35
SECONDARY
Urinary Leukotriene E4 (LTE4) Levels
171.50; 195.67; 198.00; 313.00
SECONDARY
Exhaled Nitric Oxide Measurement
14.33; 27.25; 25.75; 39.5
SECONDARY
Beclomethasone Equivalents
680; 740; 580; 1210.00
SECONDARY
Urinary Creatinine (Cr) Levels
1.7; 1.69; 1.77; 2.77
SECONDARY
Urinary Creatinine (Cr) Levels/Leukotriene E4 (LTE4) Ratio
105.87; 99.61; 159.84; 177.92

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01329939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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