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

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.

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.