Effective Treatment of Acute Sinusitis Using Nasal Steroids, Irrigation, and Oral Antibiotics A Study Targeting Different Patient Groups to Improve Sinus Infection Care

What this Trial Is About

Acute sinus infections, also called acute rhinosinusitis ARS, affect about 15% of adults annually and are a common reason for antibiotic prescriptions despite most cases being caused by viruses. This research aims to understand which patients with ARS truly benefit from antibiotics and other treatments, improving care by identifying subgroups that respond best to specific therapies. The study is a large, pragmatic, randomized controlled trial enrolling adults aged 18 to 75 with symptoms consistent with ARS. Participants enter two phases Phase 1 is a waiting period of up to 9 days with options for supportive care, during which symptom progress is monitored. Those who do not improve or who meet certain criteria move to Phase 2, where they are randomly assigned to one of four groups receiving either amoxicillinclavulanate, placebo antibiotic, amoxicillinclavulanate plus budesonide nasal spray, or placebo antibiotic plus budesonide. Treatments are given over 7 to 14 days, with dosing schedules including oral antibiotics twice daily and budesonide nasal spray once daily. Throughout both phases, participants complete daily diaries and periodic follow-ups to track symptom changes, supportive care use, and side effects. Researchers measure symptom improvement from day 1 to day 3 in Phase 2 as the primary outcome, along with additional assessments of quality of life, work productivity, adherence, and adverse events. The total study period includes up to 9 days of observation and 14 days of randomized treatment with ongoing monitoring to better target effective management for ARS.

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