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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Recruitment Status : Withdrawn (Unable to obtain FDA exemption)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

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Non 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
Estimated Study Start Date : August 13, 2019
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519061


Locations
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United States, California
Kaiser Permanante Orange County
Irvine, California, United States, 92816
Sponsors and Collaborators
Kaiser Permanente
More Information
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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03519061    
Other Study ID Numbers: Budesonide SInus Irrigations
000001 ( Other Identifier: Kaiser Permanente Southern California IRB )
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Budesonide
 Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists