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

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ClinicalTrials.gov Identifier: NCT03519061
Recruitment Status : Withdrawn (Unable to obtain FDA exemption)
First Posted : May 8, 2018
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente

Tracking Information
First Submitted Date  ICMJE April 26, 2018
First Posted Date  ICMJE May 8, 2018
Last Update Posted Date January 14, 2021
Estimated Study Start Date  ICMJE August 13, 2019
Estimated Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
SinoNasal Outcome Test (SNOT 22) [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
SNOT 22 [ Time Frame: 12 months ]
Improvement in SNOT 22 scores
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Budesonide Irrigations on Patients With Chronic Rhinosinusitis and Impact on Sinus Surgery Rates
Official Title  ICMJE Impact of Budesonide Irrigations on Patients With Chronic Rhinosinusitis and Impact on Sinus Surgery Rates
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Non randomized, single arm, prospective
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Sinus Infection
  • Chronic Sinusitis
  • Chronic Sinusitis - Ethmoidal, Posterior
  • Chronic Sinus Congestion
Intervention  ICMJE Drug: Budesonide
Nasal saline irrigations with budesonide
Study Arms  ICMJE Experimental: Treatment
This is the group of enrollees who receive budesonide
Intervention: Drug: Budesonide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 12, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 26, 2018)
200
Estimated Study Completion Date  ICMJE October 1, 2019
Estimated Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03519061
Other Study ID Numbers  ICMJE Budesonide SInus Irrigations
000001 ( Other Identifier: Kaiser Permanente Southern California IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kaiser Permanente
Study Sponsor  ICMJE Kaiser Permanente
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Kaiser Permanente
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP