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

Sponsor

Kaiser Permanente (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03519061

Collaborator

(none)

Enrollment

Location

Arm

1.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Sinus Infection Chronic Sinusitis Chronic Sinusitis - Ethmoidal, Posterior Chronic Sinus Congestion	Drug: Budesonide	Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Non randomized, single arm, prospectiveNon randomized, single arm, prospective

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 13, 2019

Anticipated Primary Completion Date :

Aug 30, 2019

Anticipated Study Completion Date :

Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment This is the group of enrollees who receive budesonide	Drug: Budesonide Nasal saline irrigations with budesonide

Arm

Intervention/Treatment

Experimental: Treatment

This is the group of enrollees who receive budesonide

Drug: Budesonide

Nasal saline irrigations with budesonide

Outcome Measures

Primary Outcome Measures

SinoNasal Outcome Test (SNOT 22) [12 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanante Orange County	Irvine	California	United States	92816

Sponsors and Collaborators

Kaiser Permanente

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kaiser Permanente

ClinicalTrials.gov Identifier:

NCT03519061

Other Study ID Numbers:

Budesonide SInus Irrigations
000001

First Posted:

May 8, 2018

Last Update Posted:

Jan 14, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Sinusitis

Chronic Disease

Budesonide

Study Results

No Results Posted as of Jan 14, 2021