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NCT06076304 · ClinicalTrials.gov registry record · Phase 4
Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis
A Phase 4 study of Sinus Infection and Acute Sinusitis, sponsored by Daniel Merenstein.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 3,720
- Enrollment target
- 7
- Study locations
NCT06076304: Recruiting Phase 4 study of Sinus Infection and Acute Sinusitis, sponsored by Daniel Merenstein.
NCT06076304 is a Phase 4 study of Sinus Infection and Acute Sinusitis that is actively recruiting participants, run by Daniel Merenstein. The registered enrollment target is 3,720 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (618% higher). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06076304, a Phase 4 study of Sinus Infection and Acute Sinusitis, is actively recruiting participants, sponsored by Daniel Merenstein.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 3,720 participants
- Enrollment target
- 7
- Study locations
Study Summary
Sinus infections (also called acute rhinosinusitis or ARS) affect about 15% of adults each year, and are one of the top reasons people receive antibiotics in outpatient settings. Since most sinus infections are caused by viruses, many patients who take antibiotics for this condition do not actually benefit. Even though this has decreased over recent years, 70% of people are still prescribed them after a visit for ARS. Our goal is to better understand which patients truly benefit from antibiotics and which other treatment options can help people with sinus infections.
Primary Outcome
Improvement of symptoms will be assessed using the Modified Sino-Nasal Outcome Test (mSNOT-16), a disease-specific quality of life questionnaire. Sixteen sinus symptoms are self-assessed on a 0-3 point scale, with 0=No Problem, 1=Mild or Slight Problem, 2=Moderate Problem, 3=Severe Problem. The mean of the total score is used to assess symptom severity. Daily measures will be collected both in Phase 1 and Phase 2.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG amoxicillin/clavulanate potassium
- DRUG Budesonide nasal spray
Study Locations (7)
California
- University of California, Los Angeles - Los Angeles
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Maryland
- MedStar Health Research Institute - Hyattsville
Pennsylvania
- Penn State College of Medicine - Hershey
Virginia
- Virginia Commonwealth University - Richmond
Washington
- University of Washington - Seattle
Wisconsin
- University of Wisconsin-Madison - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,720 participants |
| Start Date | 2023-11-21 |
| Est. Completion | 2028-12 |
| Phase | Phase 4 |
What NCT06076304 shows while recruiting
NCT06076304 is an interventional study that assigns participants to a tested intervention. Its 3,720 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (618% higher).
The record links to 2 conditions, with Sinus Infection appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06076304 lists 7 locations in 7 states (California, District of Columbia, Maryland).
Frequently Asked Questions
What is clinical trial NCT06076304 about?
NCT06076304 is a clinical study titled "Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis". Sinus infections (also called acute rhinosinusitis or ARS) affect about 15% of adults each year, and are one of the top reasons people receive antibiotics in outpatient settings. Since most sinus infections are caused by viruses, many patients who take antibiotics for this condition do not actually ...
What is the current status of trial NCT06076304?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 3,720 participants. The study started on 2023-11-21. Estimated completion is 2028-12.
What conditions does trial NCT06076304 study?
This clinical trial studies the following conditions: Sinus Infection, Acute Sinusitis.
What interventions are being tested in trial NCT06076304?
The interventions under investigation include: Placebo (DRUG), amoxicillin/clavulanate potassium (DRUG), Budesonide nasal spray (DRUG).
Who is sponsoring clinical trial NCT06076304?
This trial is sponsored by Daniel Merenstein, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06076304 being conducted?
This trial has 7 study locations across California, District of Columbia, Maryland, Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06076304's enrollment target sits among peer trials
3,720 21st of 2000 higher than 1,980 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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