Impact of Budesonide Irrigations on Patients With Chronic Rhinosinusitis and Impact on Sinus Surgery Rates

• Status: Withdrawn
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is intended to assess the impact of a 90 day course of high volume budesonide irrigations for patients who have failed other medical therapy and assessing the impact of the budesonide irrigations on the need for sinus surgery.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kaiser Permanente
• Treatments: Budesonide

Criteria

Inclusion Criteria:

• adult (>18 yo)

• symptoms consistent with sinusitis for at least 12 weeks,

• undergone maximal medical therapy, including: extended course of antibiotics (21 days minimum), use of topical corticosteroids for a minimum of 6 weeks, use of saline rinses at least once a day for a minimum of 3 weeks

• CT showing evidence of chronic sinusitis.

Exclusion Criteria:

• pregnant women,

• age below 18,

• presence of nasal polyps or other nasal masses,

• failure to complete medical therapy,

• normal CT scan,

• intolerance to budesonide or saline irrigations via squeeze bottle (high volume, high flow).