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

Chronic Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03519061
• Other study ID #: Budesonide SInus Irrigations
• Secondary ID: 000001
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: August 13, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: January 2021
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patient who meet eligibility requirements will be given the opportunity to use a budesonide saline rinse twice daily for 90 days. At the completion of this therapy, their clinical situation will be reassessed and patients will either proceed to surgery or not. If eligible patients choose not participate, they will be offered surgery up front. The study will be assessing symptom scores using the SNOT-22 validated patient reported symptoms score, CT scans, and other measures. The study hypothesizes that a significant portion of patients that otherwise would have progressed to surgery will no longer need to have surgery based upon improvements in their overall symptoms scores after using budesonise irrigations.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinus Congestion
• Chronic Sinus Infection
• Chronic Sinusitis
• Chronic Sinusitis - Ethmoidal, Posterior
• Sinusitis

Intervention

Drug:
• Budesonide
Nasal saline irrigations with budesonide

Locations

Country	Name	City	State
United States	Kaiser Permanante Orange County	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SinoNasal Outcome Test (SNOT 22)	Improvement in SNOT 22 scores, using a total score value. The total score can range from 0 to 110 in its composite score, with higher values indicating worse symptoms. The outcome would measure improvements beyond the Minimal Clinically Important Difference (MCID) score of 8.9 lower (lower indicating improvement of symptoms).	12 months