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

Kaiser Permanente logo

Kaiser Permanente

Status and phase

Withdrawn
Phase 3
Phase 2

Conditions

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

Treatments

Drug: Budesonide

Study type

Interventional

Funder types

Other

Identifiers

NCT03519061
Budesonide SInus Irrigations
000001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

Accepts 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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Treatment
Experimental group
Description:
This is the group of enrollees who receive budesonide
Treatment:
Drug: Budesonide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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