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NCT01676415 · ClinicalTrials.gov registry record · Phase 4
Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
A Phase 4 study, sponsored by Northwestern University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
NCT01676415: Clinical Trial Phase 4 study, sponsored by Northwestern University.
NCT01676415 is a Phase 4 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 9 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01676415, a Phase 4 study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the most effective route to administer steroids to patients with chronic sinusitis, specifically a type of chronic sinusitis not associated with nasal polyps (CRSsNP). The investigators would like to better understand whether orally administered steroids results in superior results when compared with nasally sprayed steroids. The investigators propose to test the hypothesis that for patients with radiographically proven CRSsNP, routine medical therapy consisting of a short course of systemic corticosteroids is superior to topical corticosteroids for relieving inflammation and the symptoms of CRS.
Primary Outcome
The Sino-nasal Outcome Test-22 is a validated questionnaire that measures 22 nasal and quality of life symptoms ("nasal obstruction" and "loss of smell and taste") ranked from 0 (not a problem) to 5 (problem as bad as it can be). Min score= 0, Max score= 110 ("worst possible problem" on all symptoms) Change from baseline of the SNOT-22 score. The SNOT-22 questionnaire is a 22-item disease-specific health related quality of life instrument validated for use in chronic rhinosinusitis.
Interventions
- DRUG Prednisone
- DRUG Topical mometasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-08 |
| Phase | Phase 4 |
Why NCT01676415 stopped before completion
NCT01676415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Prednisone is the first listed.
NCT01676415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01676415 about?
NCT01676415 is a clinical study titled "Corticosteroid Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)". The purpose of this study is to determine the most effective route to administer steroids to patients with chronic sinusitis, specifically a type of chronic sinusitis not associated with nasal polyps (CRSsNP). The investigators would like to better understand whether orally administered steroids res...
What is the current status of trial NCT01676415?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2012-08. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01676415?
The interventions under investigation include: Prednisone (DRUG), Topical mometasone (DRUG).
Who is sponsoring clinical trial NCT01676415?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01676415's enrollment target sits among peer trials
9 1968th of 2000 higher than 29 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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