Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis

NCT06076304 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: PLACER-2021C3-2447623-02-622
• Study Type: interventional
• Target: 3,720
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Sinus Infection; Acute Sinusitis

Keywords

sinusitis; antibiotics; intranasal corticosteroids; saline nasal irrigation; comparative effectiveness

Outcome Measures

Primary Outcomes (1)

• Symptom Improvement

  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.

  Change from Day 1 to Day 3 in Phase 2; differences in longitudinal trends across groups during Phase 2

Secondary Outcomes (9)

• Percent improved beyond minimal clinically important difference

  Phase 1: Baseline to Day 9; Phase 2: Day 1 to Day 3

• Patient non-randomization rate

  Phase 1: baseline to Day 9

• Supportive care

  Phase 1: Baseline to Day 9; Phase 1: Days 1, 3, 5, 7, 10, 14

• Work Productivity and Activity Impairment Questionnaire

  Phase 1: Baseline, Day 9 day; Phase 2: Days 1, 7, and 14

• Global Rating of Improvement as Quality of Life

  Phase 1: Baseline, Day 9; Phase 2: Days 1, 7, and 14

Other Outcomes (7)

• Saline nasal irrigation - Concentration

  Phase 1: daily; Phase 2; daily

• Saline nasal irrigation - Frequency

  Phase 1: daily; Phase 2; daily

• Saline nasal irrigation - Timing

  Phase 1: daily; Phase 2; daily

Study Arms (4)

antibiotic

ACTIVE COMPARATOR

amoxicillin/clavulanate

Drug: amoxicillin/clavulanate potassium

placebo antibiotic

PLACEBO COMPARATOR

placebo antibiotic (for amoxicillin/clavulanate)

Drug: Placebo

antibiotic plus intranasal corticosteroid

ACTIVE COMPARATOR

amoxicillin/clavulanate plus budesonide

Drug: amoxicillin/clavulanate potassium; Drug: Budesonide nasal spray

placebo antibiotic plus intranasal corticosteroid

OTHER

placebo antibiotic plus budesonide

Drug: Placebo; Drug: Budesonide nasal spray

Interventions

Placebo DRUG

Placebo for amoxicillin/clavulanate, oral, twice daily for 7 days

Also known as: Inactive, Control

placebo antibiotic; placebo antibiotic plus intranasal corticosteroid

amoxicillin/clavulanate potassium DRUG

Amoxicillin/clavulanate, oral, 875mg/125mg twice daily for 7 days

Also known as: Augmentin

antibiotic; antibiotic plus intranasal corticosteroid

Budesonide nasal spray DRUG

Budesonide nasal spray, 32 mcg per spray, 2 sprays per nostril, once per day

Also known as: Rhinocort

antibiotic plus intranasal corticosteroid; placebo antibiotic plus intranasal corticosteroid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old; AND are experiencing either:
• "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
• 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'').

You may not qualify if:

• allergy or intolerance to penicillin
• received systemic antibiotic therapy in the past 4 weeks
• 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

Sponsors & Collaborators

• Daniel Merenstein: lead
• Medstar Health Research Institute: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• University of Washington: collaborator
• Virginia Commonwealth University: collaborator
• University of California, Los Angeles: collaborator
• University of Wisconsin, Madison: collaborator
• Penn State College of Medicine: collaborator

Study Sites (7)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

NOT YET RECRUITING

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Sinusitis

Interventions

Amoxicillin-Potassium Clavulanate Combination; Budesonide

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dan Merenstein, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lead Project Coordinator

CONTACT

202-687-6454; researchfammed@georgetown.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research Programs, Department of Family Medicine, Principal Investigator, Professor

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 10, 2023
• Study Start: November 21, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (7)