Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis
NCT ID: NCT06076304
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
3720 participants
INTERVENTIONAL
2023-11-21
2028-12-31
Brief Summary
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Detailed Description
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To assess the comparative effectiveness of the treatments, a large, pragmatic, randomized controlled trial, will be conducted in primary and urgent care clinics within six geographical areas. Enrolled adults ages 18-75 years presenting to a clinician with symptoms consistent with ARS will enter the study in one of 2 phases, dependent on the number of days with symptoms. Phase 1 is a pre-randomization, waiting period of 9 or more days, with options for supportive care. Patients who qualify will enter Phase 2 and will be randomly assigned to one of the four arms. All groups will use approved or over-the counter drugs or spray, or a placebo (inactive or dummy pill). Patients will be in Phase 2 for approximately 14 days. All patients will complete a two-minute daily diary and periodic follow-ups about their symptoms.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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antibiotic
amoxicillin/clavulanate
Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral Tablet
Amoxicillin/clavulanate, oral, 875mg/125mg twice daily for 7 days
C-reactive protein
Measurement of C-reactive protein level in capillary blood
placebo antibiotic
placebo antibiotic, amoxicillin/clavulanate
Placebo
Placebo for amoxicillin/clavulanate, oral, twice daily for 7 days
C-reactive protein
Measurement of C-reactive protein level in capillary blood
antibiotic plus intranasal corticosteroid
amoxicillin/clavulanate plus budesonide
Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral Tablet
Amoxicillin/clavulanate, oral, 875mg/125mg twice daily for 7 days
Budesonide nasal spray
Budesonide nasal spray, 32 mcg per spray, 2 sprays per nostril, once per day
C-reactive protein
Measurement of C-reactive protein level in capillary blood
placebo antibiotic plus intranasal corticosteroid
placebo antibiotic plus budesonide
Placebo
Placebo for amoxicillin/clavulanate, oral, twice daily for 7 days
Budesonide nasal spray
Budesonide nasal spray, 32 mcg per spray, 2 sprays per nostril, once per day
C-reactive protein
Measurement of C-reactive protein level in capillary blood
Interventions
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Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral Tablet
Amoxicillin/clavulanate, oral, 875mg/125mg twice daily for 7 days
Placebo
Placebo for amoxicillin/clavulanate, oral, twice daily for 7 days
Budesonide nasal spray
Budesonide nasal spray, 32 mcg per spray, 2 sprays per nostril, once per day
C-reactive protein
Measurement of C-reactive protein level in capillary blood
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. "persistent" symptoms or signs compatible with ARS or sinus infection lasting for 1-21 days without any evidence of clinical improvement (Symptoms include facial pain or pressure, facial congestion or fullness, nasal obstruction, nasal discharge, no or reduced sense of smell, fever ≤39°C or 102°F, headache, bad smelling breath, fatigue, ear pain or pressure, and dental pain); OR
3. onset with worsening symptoms or signs characterized by the new onset of fever, headache, or increase in nasal discharge following a typical viral upper respiratory infection (URI) that lasted 5-6 days and were initially improving (''double-sickening'').
Exclusion Criteria
* received systemic antibiotic therapy in the past 4 weeks
* prior sinus surgery (cosmetic surgery, such as rhinoplasty, septal deviation, etc. are not exclusionary)
* complications of sinusitis (facial edema (swelling), cellulitis), or orbital, meningeal or cerebral signs)
* health care clinician determined IV (intravenous) antibiotics or hospital admission are required
* pregnancy or breastfeeding
* presence of a comorbidity or medication that may impair a patient's immune response as determined by a health care clinician
* hospitalization in past 5 days
* unable or unwilling to provide informed consent or comply with study protocol requirements
* fever \>39°C or 102°F today
* taking intranasal corticosteroids (INCS) regularly in the past two weeks and unwilling to stop its use while in the study; OR
* previously enrolled or participated in the feasibility phase or this stage of study
18 Years
75 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Medstar Health Research Institute
OTHER
Penn State College of Medicine
UNKNOWN
University of Washington
OTHER
Virginia Commonwealth University
OTHER
University of California, Los Angeles
OTHER
University of Wisconsin, Madison
OTHER
Daniel Merenstein
OTHER
Responsible Party
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Daniel Merenstein
Director of Research Programs, Department of Family Medicine, Principal Investigator, Professor
Principal Investigators
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Dan Merenstein, MD
Role: PRINCIPAL_INVESTIGATOR
Georgetown University
Locations
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University of California, Los Angeles
Los Angeles, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
MedStar Health Research Institute
Hyattsville, Maryland, United States
Penn State College of Medicine
Hershey, Pennsylvania, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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23-02-622
Identifier Type: OTHER
Identifier Source: secondary_id
PLACER-2021C3-24476
Identifier Type: -
Identifier Source: org_study_id
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