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NCT06830109 · ClinicalTrials.gov registry record · Phase 2
Nasal Obstruction With Oxymetazoline and Corticosteroids
A Phase 2 study of Nasal Obstruction, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06830109: Recruiting Phase 2 study of Nasal Obstruction, sponsored by Washington University School of Medicine.
NCT06830109 is a Phase 2 study of Nasal Obstruction that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 80 participants, below the 146-participant average among 4 other Nasal Obstruction trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06830109, a Phase 2 study of Nasal Obstruction, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to examine the efficacy and safety of commination oxymetazoline/intranasal steroids for long-term management of chronic nasal obstruction that is recalcitrant to the current standard of care. The investigators hypothesize that combination treatment with oxymetazoline and intranasal corticosteroid spray will provide a larger reduction in nasal obstruction than intranasal corticosteroid alone for patients suffering from chronic nasal obstruction, and there will not be occurrences of rhinitis medicamentosa.
Primary Outcome
The primary outcome measure will be the rate of responders (as a percentage) to the intervention defined as the number of participants reporting 2 (Moderately Improved), or 3 (Much Improved) in the Clinical Global Impression of Improvement (CGI-I) assessed after 4 weeks of treatment divided by the total number of participants in each study group. CGI-I asks subjects to rate their overall response to treatment using a 7-point Likert scale ranging from -3 to 3 ("Much Worse" to "Much Improved"). P
Conditions Studied
Interventions
- DRUG Budesonide nasal spray
- DRUG Oxymetazoline Nasal Spray
Study Locations (1)
Missouri
- Washington University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-10-15 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 2 |
What NCT06830109 shows while recruiting
NCT06830109 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 146-participant average among 4 other Nasal Obstruction trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Nasal Obstruction appearing as the primary indexed condition, and to 2 interventions - of which Budesonide nasal spray is the first listed.
NCT06830109 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT06830109 about?
NCT06830109 is a clinical study titled "Nasal Obstruction With Oxymetazoline and Corticosteroids". This study aims to examine the efficacy and safety of commination oxymetazoline/intranasal steroids for long-term management of chronic nasal obstruction that is recalcitrant to the current standard of care. The investigators hypothesize that combination treatment with oxymetazoline and intranasal c...
What is the current status of trial NCT06830109?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2024-10-15. Estimated completion is 2026-12-30.
What conditions does trial NCT06830109 study?
This clinical trial studies the following conditions: Nasal Obstruction.
What interventions are being tested in trial NCT06830109?
The interventions under investigation include: Budesonide nasal spray (DRUG), Oxymetazoline Nasal Spray (DRUG).
Who is sponsoring clinical trial NCT06830109?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06830109 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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