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Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS)

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
No Placebo-Only Group

Summary

This trial is testing a special nasal rinse with nitric oxide to help patients with stubborn sinus infections. The nitric oxide helps kill bacteria and clear the infection, which doesn't respond well to usual treatments.

Eligible Conditions
  • 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,066 Total Patients Enrolled
1 Trials studying Sinusitis
162 Patients Enrolled for Sinusitis
Amin Javer, MDPrincipal InvestigatorSt. Paul's Hospital
5 Previous Clinical Trials
376 Total Patients Enrolled
5 Trials studying Sinusitis
376 Patients Enrolled for Sinusitis
~9 spots leftby Dec 2025
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