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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: Completed Phase 4 study, sponsored by University of Louisville.
NCT00560586 is a Phase 4 study that has completed, run by University of Louisville. The registered enrollment target is 62 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Subjects will complete a sleep study with polysomnography at beginning of treatment and 6 weeks after start of treatment. Analysis of the sleep study will provide the number of times the subject has apnea (temporary cessation of breathing) or hypopnea (slow or shallow breathing)
Interventions
- DRUG placebo
- DRUG Budesonide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2004-04 |
| Est. Completion | 2007-08 |
| Phase | Phase 4 |
What the finished NCT00560586 record still lists
NCT00560586 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00560586 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00560586's enrollment target sits among peer trials
62 1110th of 2000 higher than 882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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