Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDaniel Merenstein
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
"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'').
Disqualifiers
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)
Trial design
Design model
Factorial
Treatments tested in this trial
amoxicillin/clavulanate potassium
DrugAmoxicillin/clavulanate, oral, 875mg/125mg twice daily for 7 days
Placebo
DrugPlacebo for amoxicillin/clavulanate, oral, twice daily for 7 days
Budesonide nasal spray
DrugBudesonide nasal spray, 32 mcg per spray, 2 sprays per nostril, once per day
Treatment groups
3,720 Participants
are divided into 4 treatment groupsGroup A: antibioticActive comparator 1 intervention
Group B: placebo antibioticPlacebo comparator 1 intervention
Group C: antibiotic plus intranasal corticosteroidActive comparator 2 interventions
Group D: placebo antibiotic plus intranasal corticosteroidOther 2 interventions
Trial outcomes
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.
Time frame
Change from Day 1 to Day 3 in Phase 2; differences in longitudinal trends across groups during Phase 2Secondary outcomes
1
Percent improved beyond minimal clinically important difference
Percent of patients who improved more than 0.5; 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.
Time frame
Phase 1: Baseline to Day 9; Phase 2: Day 1 to Day 32
Patient non-randomization rate
Percentage of patients who were enrolled in Phase 1 but did not proceed to randomization because they reported their condition had improved. This is determined by the patient at the Day 9 assessment, by decreased mSNOT-16 scores from baseline, or no longer reports symptoms listed in the inclusion criteria.
Time frame
Phase 1: baseline to Day 93
Supportive care
Types and frequency of supportive care used.
Time frame
Phase 1: Baseline to Day 9; Phase 1: Days 1, 3, 5, 7, 10, 144
Work Productivity and Activity Impairment Questionnaire
Work and activity impairment due to acute sinusitis; the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem 2.0 is a 6-question self-reported questionnaire on the effects of sinus symptoms on the amount of absenteeism (percent work time missed), presenteeism (percent impairment while working), overall work impairment, and daily activity impairment. Higher percentages indicate greater impairment and less productivity (scale 0-100%).
Time frame
Phase 1: Baseline, Day 9 day; Phase 2: Days 1, 7, and 14Other outcomes
1
Saline nasal irrigation - Concentration
Number who used 0.9 or 2% saline concentration
Time frame
Phase 1: daily; Phase 2; daily2
Saline nasal irrigation - Frequency
Number who used SNI 1, 2 or 3 times per day
Time frame
Phase 1: daily; Phase 2; daily3
Saline nasal irrigation - Timing
Number who used SNI before 12 pm or after 12 pm
Time frame
Phase 1: daily; Phase 2; daily4
C-reactive protein (CRP)
Measurement of C-reactive protein (CRP) level as a predictor of bacterial infection, of not improving in Phase 1 and proceeding to Phase 2, and of poorer outcomes in non-antibiotic groups
Time frame
Phase 1 and Phase 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Daniel Merenstein
Lead sponsor
Georgetown University
Sponsor institution
Patient-Centered Outcomes Research Institute
Collaborator
Medstar Health 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
Source ClinicalTrials.gov