Acute Sinusitis Clinical Trial
— NOSESOfficial title:
Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis - Pilot
Verified date | May 2024 |
Source | Georgetown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
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 |
United States,
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 |
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