CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Montelukast +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01329939
NCT01329939N/ACompleted

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

Northwell Health·interventional·Posted Apr 6, 2011·Updated Apr 7, 2016

In Brief

A clinical study evaluating Montelukast and Placebo for Asthma and 2 related conditions. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2011
Enrollment StartApr 1, 2011
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.2 years ago

Interventions

Montelukastdrug

Age-dependent dose, nightly, 24 weeks

Placebodrug

Age-dependent dose, nightly, 24 weeks

Montelukastdrug

Age-dependent dose, nightly, 24 weeks

Placebodrug

Age-dependent dose, nightly, 24 weeks