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NCT00560586 · ClinicalTrials.gov registry record · Phase 4
Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome
A Phase 4 study, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 4
- Development phase
- 62
- Enrollment target
NCT00560586 is a Phase 4 study that has completed, run by University of Louisville. The registered enrollment target is 62 participants.
The verdict
NCT00560586, a Phase 4 study, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 62 participants
- Enrollment target
Study Summary
-Intranasal budesonide therapy may lead to improved symptoms and sleep study findings in children with mild obstructive sleep apnea with and without allergic rhinitis that would not be treated with T\&A. The aim of the study is to conduct a randomized double blind cross-over trial comparing the effect of once a day intranasal budesonide therapy vs. placebo in children with mild sleep apnea that would not be candidates for T\&A.
Interventions
- DRUG placebo
- DRUG Budesonide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2004-04 |
| Est. Completion | 2007-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00560586
The ClinicalTrials.gov registry entry for NCT00560586 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00560586 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00560586 about?
NCT00560586 is a clinical study titled "Nasal Budesonide in Children With Rhinitis and/or Mild Obstructive Sleep Apnea Syndrome". -Intranasal budesonide therapy may lead to improved symptoms and sleep study findings in children with mild obstructive sleep apnea with and without allergic rhinitis that would not be treated with T\&A. The aim of the study is to conduct a randomized double blind cross-over trial comparing the effe...
What is the current status of trial NCT00560586?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 62 participants. The study started on 2004-04. Estimated completion is 2007-08.
What interventions are being tested in trial NCT00560586?
The interventions under investigation include: placebo (DRUG), Budesonide (DRUG).
Who is sponsoring clinical trial NCT00560586?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
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