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

Primary Purpose

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

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Budesonide

About this trial

This is an interventional treatment trial for Chronic Sinus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Kaiser Permanante Orange County

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

This is the group of enrollees who receive budesonide

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT03519061

First Posted

April 26, 2018

Last Updated

January 12, 2021

Sponsor

Kaiser Permanente

1. Study Identification

Unique Protocol Identification Number

NCT03519061

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Unable to obtain FDA exemption

Study Start Date

August 13, 2019 (Anticipated)

Primary Completion Date

August 30, 2019 (Anticipated)

Study Completion Date

October 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kaiser Permanente

4. Oversight

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.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Model Description

Non randomized, single arm, prospective

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

This is the group of enrollees who receive budesonide

Intervention Type

Drug

Intervention Name(s)

Budesonide

Intervention Description

Nasal saline irrigations with budesonide

Primary Outcome Measure Information:

Title

SinoNasal Outcome Test (SNOT 22)

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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).

Facility Information:

Facility Name

Kaiser Permanante Orange County

City

Irvine

State/Province

California

ZIP/Postal Code

92816

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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