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NCT01329939 · ClinicalTrials.gov registry record · NA
The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics
A NA study, sponsored by Northwell Health.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT01329939 is a NA study that has completed, run by Northwell Health. The registered enrollment target is 26 participants.
The verdict
NCT01329939, a NA study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Montelukast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01329939
The ClinicalTrials.gov registry entry for NCT01329939 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01329939 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01329939 about?
NCT01329939 is a clinical study titled "The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics". 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 ...
What is the current status of trial NCT01329939?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2011-04. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01329939?
The interventions under investigation include: Placebo (DRUG), Montelukast (DRUG).
Who is sponsoring clinical trial NCT01329939?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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