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

Acute Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06076304
• Other study ID #: PLACER-2021C3-24476
• Secondary ID: 23-02-622
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 21, 2023
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sinus infections are sometimes treated with antibiotics or nasal 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. The overall goal of this clinical trial to see which patients with sinus infections are more likely to respond to different treatments, and which improve with supportive care alone.

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 practice-based research networks within six geographical areas. Enrolled adults ages 18-65 years presenting to a clinician with symptoms consistent with ARS for less than 10 days will begin with a pre-randomization period with options for supportive care. Patients who reached more than 9 days of symptoms at the time of enrollment or during the waiting period will be randomly assigned to one of the four treatment arms. In preparation for the full-scale trial, a smaller feasibility study of the protocol will be piloted in a subset of clinics within the same research networks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

? 18-65 years old; AND experiencing ongoing symptoms or signs that suggest an acute sinus infection lasting for 1-21 days, without any signs clinical improvement

Exclusion Criteria:

• allergy or intolerance to penicillin
• received systemic antibiotic therapy in the past 4 weeks
• prior sinus surgery
• 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
• unable to read, speak or understand English or Spanish
• hospitalization in past 5 days
• unable or unwilling to provide informed consent or comply with study protocol requirements
• fever >39°C or 102°F; OR
• taking intranasal corticosteroids (INCS) regularly in the past two weeks

Related Conditions & MeSH terms

• Acute Sinusitis
• Sinus Infection
• Sinusitis

Intervention

Drug:
• Amoxicillin/clavulanate
Amoxicillin/clavulanate, oral, 875mg/125mg twice daily for 7 days
• Placebo antibiotic
Placebo antibiotic, oral, twice daily for 7 days
• Budesonide nasal spray
Budesonide nasal spray, 32 mcg per spray, 2 sprays per nostril, once per day

Other:
• C-reactive protein
Measurement of C-reactive protein level in capillary blood
• Mid-turbinate swab (optional)
Optional collection of mid-turbinate nasal swab sample

Locations

Country	Name	City	State
United States	Penn State College of Medicine	Hershey	Pennsylvania
United States	MedStar Health Research Institute	Hyattsville	Maryland
United States	University of California Los Angeles	Los Angeles	California
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Washington	Seattle	Washington
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (8)

Lead Sponsor	Collaborator
Daniel Merenstein	Medstar Health Research Institute, Patient-Centered Outcomes Research Institute, Penn State College of Medicine, University of California, Los Angeles, University of Washington, University of Wisconsin, Madison, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Saline nasal irrigation	Number of patients reporting use of saline nasal irrigation during the pre- and post-randomization study periods.	Baseline to 14 days post-randomization
Other	Watchful waiting	Number of patients who experienced improvement or resolution of symptoms during the pre-randomization period (between enrollment and 9 days of symptoms).	Baseline to 9 days of symptoms
Other	Adherence	Self-reported adherence to study pill and nasal spray are calculated by [number of doses taken]/[prescribed number of doses] x 100, over the 7-day intervention period.	Days 1-7 post-randomization
Other	C-reactive protein (CRP)	Measurement of C-reactive protein (CRP) level in capillary blood	Baseline
Primary	Improvement of symptoms	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. Scores will be measured at baseline and 3 days post-randomization.	Baseline and 3 days post-randomization
Secondary	Improvement of symptoms	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. Scores will be measured at daily from baseline until 14 days post-randomization.	Baseline to 14 days post-randomization
Secondary	Work Productivity and Activity Impairment Questionnaire	The Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI: SHP) 2.0 is a 6-question self-reported questionnaire on the effects of sinus symptoms on the amount of absenteeism, presenteeism, work impairment, and daily activity impairment. WPAI will be assessed at baseline, 9 days of symptoms is reached, and 1, 7, and 14 days post-randomization.	Baseline, 9 days of symptoms, and 1, 7, and 14 days post-randomization
Secondary	Global Rating of Improvement	Self-assessment of current sinus symptoms at each follow-up interview using a 6-point categorical scale (1=no symptoms, 2=a lot better, 3=a little better, 4=the same, 5=a little worse, or 6=a lot worse). Scores will be measured at baseline, when 9 days of symptoms is reached, and 3, 7, and 14 days post-randomization.	Baseline, 9 days of symptoms, and 3, 7, and 14 days post-randomization
Secondary	Symptomatic care	Number of patients reporting use of over-the-counter medicines or supplements during the pre- and post-randomization study periods.	Baseline to 14 days post-randomization
Secondary	Adverse events	Number of adverse events reported during a follow-up or on the diary during the the pre- and post-randomization study periods. Events are graded form 1-5 using the NCI Common Terminology Criteria for Adverse Events.	Baseline to 14 days post-randomization