Clinical trial NCT06076304: Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis
Official title: Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Sinus Infection
Acute Sinusitis
Keywords: sinusitis
antibiotics
intranasal corticosteroids
saline nasal irrigation
comparative effectiveness
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Medstar Health Research Institute
name: Penn State College of Medicine
name: University of Washington
name: Virginia Commonwealth University
name: University of California, Los Angeles
name: University of Wisconsin, Madison
First posted: 2023-10-10
Enrollment: 3720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Sinus infections are sometimes treated with oral antibiotics or nasal steroid sprays, while some patients get better on their own. Some patients may wait a few days or use common over-the-counter remedies to see if their symptoms improve without further treatment. Sometimes this is enough to help patients wait a few days to see if their infection clears up without needing to use antibiotics or nasal steroid sprays. The overall goal of this clinical trial to see which specific groups of patients benefit more from which intervention or combination of intervention, and which improve with supportive care alone.

Detailed description: One in seven adults are diagnosed with acute sinus infections (also known as rhinosinusitis or ARS) every year in the United States, for an annual total of 30 million office visits. Most acute sinus infections seen in outpatient setting are caused by viral infection, but antibiotics are prescribed in over 70% of these visits. The overarching goal is to improve outcomes for patients with ARS by understanding which subgroups are most likely to benefit from antibiotics, supportive care, watchful waiting, intranasal corticosteroids (INCS), or a combination of treatments.

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.

Eligibility criteria: Inclusion Criteria:

1. 18-75 years old; AND are experiencing either:
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:

* allergy or intolerance to penicillin
* 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

Primary outcomes:
measure: Improvement of symptoms
timeFrame: day 1 and 3 days post-randomization
Secondary outcomes:
measure: Improvement of symptoms
timeFrame: baseline to 14 days post-randomization
measure: Work Productivity and Activity Impairment Questionnaire
timeFrame: Baseline, 9 days of symptoms, and 1, 7, and 14 days post-randomization
measure: Global Rating of Improvement
timeFrame: Baseline, 9 days of symptoms, and 3, 7, and 14 days post-randomization
measure: Symptomatic care
timeFrame: Baseline to 14 days post-randomization
measure: Adverse events
timeFrame: Baseline to 14 days post-randomization
Other outcomes:
measure: Saline nasal irrigation
timeFrame: Baseline to 14 days post-randomization
measure: Watchful waiting
timeFrame: Baseline to 9 days of symptoms
measure: Adherence
timeFrame: Days 1-7 post-randomization
measure: C-reactive protein (CRP)
timeFrame: Baseline
measure: Other signs and symptoms of ARS
timeFrame: Baseline to 14 days post-randomization
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Hyattsville
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: Georgetown University
name: Dan Merenstein, MD
role: PRINCIPAL_INVESTIGATOR
References: