Chronic Sinusitis Clinical Trial
Official title:
Phase 2 Trial to Evaluate Safety & Efficacy of Topical Nitric Oxide Releasing Sinus Irrigation (NOSi) as Compared to Budesonide-Saline (Control) in the Management of Biofilm-Associated Recalcitrant Chronic Rhinosinusitis (RCRS)
This a single center, randomized controlled trial to evaluate safety & efficacy of topical nitric oxide releasing sinus irrigation (NOSi) as compared to budesonide-Saline (Control) in the management of biofilm-associated recalcitrant chronic rhinosinusitis (RCRS). It is hypothesized that a daily treatment of NOSi over a 6-week period will be safe and effective at reducing clinical symptoms associated with RCRS.
This is a prospective, single center, Phase 2, double-blinded, randomized, controlled, parallel group trial study. Up to fifty-four (54) participants will be enrolled (based on power analysis based on outcomes from a previous dose-tolerance study. Screening data will be reviewed to determine participant eligibility. Participants who meet all inclusion criteria and none of the exclusion criteria will be entered into the study and randomized in to the Investigational Medicinal Product (IMP) or Non Investigational Medicinal Product (NIMP) at a 2:1 ratio (NOSi:Budesonide). Each participant will be managed as an outpatient for the 42 days of the study. Participants will be administered NOSi or budesonide in saline by self-administration, at home, as a sinus irrigation to their nasopharynx and sinuses once a day. Participants will be asked to return to the clinic for evaluations on Day 21(±2), Day 43(±2) and Day 63 (±2) following the start of study interventions. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02266810 -
Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus
|
Phase 3 | |
| Completed |
NCT01706484 -
Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Chronic Rhinosinusitis
|
Phase 3 | |
| Completed |
NCT01197612 -
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
|
Phase 3 | |
| Completed |
NCT04418622 -
Evolution of the Endonasal Microbiota in Patients With Chronic Rhinosinusitis
|
||
| Not yet recruiting |
NCT06070311 -
Wound Healing After Endoscopic Sinus Surgery
|
N/A | |
| Not yet recruiting |
NCT05454163 -
Post-radiotherapy Rhinosinusitis in Children
|
||
| Withdrawn |
NCT01185808 -
Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps
|
N/A | |
| Completed |
NCT01700725 -
Gulf War Illness Nasal Irrigation Study
|
Phase 2 | |
| Withdrawn |
NCT00671281 -
The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery
|
N/A | |
| Completed |
NCT00447837 -
Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis
|
Phase 2 | |
| Recruiting |
NCT04362501 -
Efficacy of Dupilumab for Patients With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
|
Phase 2 | |
| Completed |
NCT05035654 -
LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
|
Phase 2 | |
| Completed |
NCT02562924 -
The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery
|
N/A | |
| Completed |
NCT01007799 -
Vitamin D for Chronic Sinusitis
|
N/A | |
| Completed |
NCT03358329 -
Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE)
|
Phase 3 | |
| Withdrawn |
NCT02981017 -
Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure
|
N/A | |
| Completed |
NCT04041609 -
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
|
Phase 2 | |
| Recruiting |
NCT01854619 -
Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis
|
N/A | |
| Completed |
NCT00924404 -
Xylitol Versus Saline in Chronic Sinusitis
|
N/A | |
| Not yet recruiting |
NCT03903432 -
The Feasibility of Using MRI During ESS
|
N/A |