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

NCT03519061 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: Budesonide SInus Irrigations000001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Sinus Infection; Chronic Sinusitis; Chronic Sinusitis - Ethmoidal, Posterior; Chronic Sinus Congestion

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment

EXPERIMENTAL

This is the group of enrollees who receive budesonide

Drug: Budesonide

Interventions

Budesonide DRUG

Nasal saline irrigations with budesonide

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanante Orange County

Irvine, California, 92816, United States

Location

MeSH Terms

Interventions

Budesonide

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non randomized, single arm, prospective

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 8, 2018
• Study Start: August 13, 2019
• Primary Completion: August 30, 2019
• Study Completion: October 1, 2019
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)