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Nitric Oxide for Chronic Sinusitis

Phase 2
Waitlist Available
Led By Amin Javer, MD
Research Sponsored by Sanotize Research and Development corp.
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 days 21, 42, 63
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of using a topical nitric oxide releasing solution for sinus irrigation to a control solution of budesonide and saline in managing biofilm-associated recalcitrant chronic rhinosinusitis.

Eligible Conditions
  • Chronic Sinusitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 21, 42, 63
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 21, 42, 63 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To assess the efficacy of NOSi compared to Budesonide on disease specific quality of life in participants with biofilm-associated recalcitrant chronic rhinosinusitis (RCRS) as measured by the Sino-Nasal Outcome Test (SNOT-22)
To assess the safety of NOSi compared to Budesonide on disease specific quality of life in participants with biofilm-associated recalcitrant chronic rhinosinusitis
Secondary outcome measures
Budesonide
To evaluate the efficacy of NOSi compared to Budesonide on cilia functionality
To evaluate the efficacy of NOSi compared to Budesonide on quality of life improvements (EQ-5D-5L);
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Nitric oxide releasing solution (NOSi)Experimental Treatment1 Intervention
DailyTopical sinus irrigation delivery of 240mL NOSi
Group II: Budesonide -salineActive Control1 Intervention
Daily Topical sinus irrigation delivery of 240 mL of 1 mg Budesonide-saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitric Oxide
2004
Completed Phase 4
~1280

Find a Location

Who is running the clinical trial?

Sanotize Research and Development corp.Lead Sponsor
8 Previous Clinical Trials
2,094 Total Patients Enrolled
Amin Javer, MDPrincipal InvestigatorSt. Paul's Hospital
5 Previous Clinical Trials
376 Total Patients Enrolled
1 Trials studying Chronic Sinusitis
100 Patients Enrolled for Chronic Sinusitis
~10 spots leftby Jun 2025
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