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Corticosteroid

Treatment for Chronic Sinusitis

Phase 2 & 3
Waitlist Available
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.

Eligible Conditions
  • Chronic Sinusitis
  • Chronic Sinus Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
SinoNasal Outcome Test (SNOT 22)

Side effects data

From 2016 Phase 4 trial • 222 Patients • NCT02055352
9%
Nasopharyngitis
9%
Influenza
8%
Headache
7%
Dysphonia
6%
Urinary tract infection
6%
Arthralgia
5%
Back pain
2%
Chronic obstructive pulmonary disease
1%
Peripheral arterial occlusive disease
1%
Vascular insufficiency
1%
Venous thrombosis limb
1%
Acute myocardial infarction
1%
Cor pulmonale
1%
Nodal arrhythmia
1%
Pneumonia
1%
Hip fracture
1%
Hepatocellular carcinoma
1%
Acute pulmonary oedema
1%
Bradycardia
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluticasone / Salmeterol (B)
Budesonide / Indacaterol (A)

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
This is the group of enrollees who receive budesonide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budesonide
FDA approved

Find a Location

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
552 Previous Clinical Trials
27,702,257 Total Patients Enrolled
~0 spots leftby Oct 2025
Unbiased ResultsWe believe in providing patients with all the options.
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