Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-01-07 @ 8:31 PM
Study NCT ID:
NCT00599534
Status:
WITHDRAWN
Last Update Posted:
2017-04-10
First Post:
2008-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controlled Trial on Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome
Sponsor:
University of Louisville
Organization:
Study Overview
Official Title:
A Randomized Double Blind Controlled Trial on the Effect of Treatment in Children With Obstructive Sleep Apnea Syndrome.
Status:
WITHDRAWN
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator has transferred to another Institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oral therapy with montelukast may lead to improved polysomnographic findings in children with mild to moderate OSAS with and without allergic rhinitis who a priori require T\&A for OSAS.
\- A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will obviate the need for surgical T\&A.
\- A significant proportion of the children with OSAS treated with montelukast will show reduced severity of OSAS, and this will obviate the need for surgical T\&A.
Detailed Description:
Primary Specific Aim. To conduct a randomized double blind 16-week trial comparing the effect on polysomnographic measures of the administration of once a day oral montelukast therapy vs. placebo in children with OSAS.
Secondary Specific Aim. For all children with the original AHI at diagnosis of \>2 hrTST, we expect improvements in the severity of sleep apnea to occur following treatment with montelukast. Therefore, we will examine the overall reduction in AHI and also how many of these children have AHI\< 2 after the 16-week treatment. In other words, the percentage of children converting from needing T\&A surgery before treatment with montelukast to not needing surgery after treatment will be examined.
Secondary Specific Aim. For all children with the original AHI at diagnosis of \>2 hrTST, we expect improvements in the severity of sleep apnea to occur following treatment with montelukast. Therefore, we will examine the overall reduction in AHI and also how many of these children have AHI\< 2 after the 16-week treatment. In other words, the percentage of children converting from needing T\&A surgery before treatment with montelukast to not needing surgery after treatment will be examined.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: