Clinical trials: Rhinosinusitis With Polyps
Nasal Polyps, Chronic Rhinosinusitis
A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to…
- Trial name
- POLYP 2 (NCT03280537)
- Testing
- Omalizumab
- Where
- 45 sites in United States, Belgium and 8 more
- Volunteers
- 127 people
- Sponsor
- Hoffmann-La Roche
Chronic Sinusitis, Nasal Polyps
Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps
The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.
- Trial name
- RESOLVE (NCT01732536)
- Testing
- S8 Sinus Implant, Mometasone furoate nasal spray
- Where
- 19 sites in United States
- Volunteers
- 100 people
- Sponsor
- Intersect ENT
Chronic Rhinosinusitis
Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps
This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with…
- Trial name
- NCT03781804
- Testing
- OPN-375
- Where
- 92 sites in United States, Bulgaria and 6 more
- Volunteers
- 332 people
- Sponsor
- Optinose US Inc.
Nasal Polyps, Aspirin-exacerbated Respiratory Disease
Role of IL-5R Signaling in Non-eosinophil Upper Airway Cells in CRSwNP
The overarching hypothesis of this proposal is that IL-5 acts on multiple sinus tissue cell types, including plasma cells and epithelial cells, to promote immune dysregulation, and that inhibition of IL-5 affects several relevant…
- Trial name
- RECAP-5 (NCT05672030)
- Testing
- Non-Interventional
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Chronic Rhinosinusitis, Nasal Polyps
Subcutaneous Omalizumab for Treatment of Chronic Rhinosinusitis With Nasal Polyposis
The investigators are doing this research study to learn more about a drug called Xolair (omalizumab). The investigators want to see if it is an effective treatment for chronic rhinosinusitis (CRS).
- Trial name
- NCT01066104
- Testing
- Xolair (omalizumab)
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Massachusetts General Hospital
Nasal Polyps, Chronic Rhinosinusitis
An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
The overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult participants with chronic rhinosinusitis with nasal polyps who completed the…
- Trial name
- NCT03478930
- Testing
- Omalizumab
- Where
- 79 sites in United States, Belgium and 12 more
- Volunteers
- 249 people
- Sponsor
- Hoffmann-La Roche
Nasal Polyps
Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS)
This is a randomized, double blind, placebo controlled, parallel group phase III study designed to assess the clinical efficacy and safety of 100 milligrams (mg) subcutaneous (SC) mepolizumab treatment in adults with CRSwNP/ECRS…
- Trial name
- MERIT (NCT04607005)
- Testing
- Mepolizumab, Standard of care
- Where
- Japan
- Volunteers
- 169 people
- Sponsor
- GlaxoSmithKline
Chronic Rhinosinusitis, Endoscopic Sinus Surgery
Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)
While oral steroids have been shown to be effective in the management of patients with chronic rhinosinusitis with polyps, its role in treating chronic rhinosinusitis without polyps (CRSsNP) is ambiguous.
- Conditions
- Chronic Rhinosinusitis, Endoscopic Sinus Surgery, Chronic Rhinosinusitis Without Polyps, Oral Steroids
- Trial name
- NCT02748070
- Testing
- Prednisone, Flonase
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Stanford University
Chronic Rhinosinusitis With Nasal Polyps
Dupilumab in Chinese Adult Participants With CRSwNP
This is a parallel group, Phase 3, 2-arm study for treatment. The purpose of this study is to evaluate dupilumab subcutaneous (SC) injections compared to placebo in Chinese adult participants with CRSwNP, on a background therapy…
- Trial name
- NCT05878093
- Testing
- Dupilumab, Budesonide
- Where
- 18 sites in China
- Volunteers
- 63 people
- Sponsor
- Sanofi
Chronic Rhinosinusitis With Nasal Polyps
Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis
A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants with Severe Chronic Rhinosinusitis with Nasal Polyposis
- Trial name
- WAYPOINT (NCT04851964)
- Testing
- Experimental: Tezepelumab, Mometasone furoate or equivalent intranasal corticosteroid
- Where
- 112 sites in United States, Canada and 8 more
- Volunteers
- 416 people
- Sponsor
- AstraZeneca
Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)
A Controlled Clinical Study of Dupilumab in Patients With Bilateral Nasal Polyps
Primary Objective: To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity…
- Trial name
- SINUS-24 (NCT02912468)
- Testing
- Dupilumab SAR231893 (REGN668), Mometasone furoate 50 micrograms
- Where
- 76 sites in United States, Bulgaria and 11 more
- Volunteers
- 276 people
- Sponsor
- Sanofi
Chronic Rhinosinusitis With Nasal Polyps, Asthma
EValuating trEatment RESponses of Dupilumab Versus Omalizumab in Type 2 Patients
Primary Objective -To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell Secondary Objectives To evaluate the efficacy of dupilumab in improving chronic…
- Trial name
- EVEREST (NCT04998604)
- Testing
- Dupilumab, Omalizumab
- Where
- 87 sites in United States, Belgium and 15 more
- Volunteers
- 360 people
- Sponsor
- Sanofi
Nasal Polyposis, Eosinophilic Chronic Rhinosinusitis
Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)
This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus…
- Trial name
- ORCHID (NCT04157335)
- Testing
- Benralizumab 30 mg
- Where
- 116 sites in United States, Argentina and 15 more
- Volunteers
- 295 people
- Sponsor
- AstraZeneca
Chronic Sinusitis, Nasal Polyposis
S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps
The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.
- Trial name
- RESOLVE_II (NCT02291549)
- Testing
- S8 Sinus Implant, Mometasone furoate nasal spray
- Where
- 40 sites in United States
- Volunteers
- 300 people
- Sponsor
- Intersect ENT
Chronic Rhinosinusitis With Nasal Polyps
Mechanisms of Smell Improvement With Dupilumab.
This study seeks to explore the mechanism through which dupilumab improves olfactory cleft inflammation in patients with chronic sinusitis with nasal polyps (CRSwNP).
- Trial name
- NCT05964465
- Testing
- Dupilumab
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medical University of South Carolina
Chronic Rhinosinusitis
Etokimab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
A study to evaluate the safety and efficacy of multiple doses of etokimab in adults with chronic rhinosinusitis with nasal polyps.
- Trial name
- NCT03614923
- Testing
- Etokimab, Mometasone Furoate Nasal Spray
- Where
- 28 sites in United States
- Volunteers
- 105 people
- Sponsor
- AnaptysBio, Inc.
Asthma, Aspirin-Induced, Chronic Rhinosinusitis With Nasal Polyps
Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab)
Primary objective: to investigate the efficacy of Mepolizumab 100 milligram (mg) every month compared to placebo in reducing validated Sinonasal Outcome Test -22 score and on reducing endoscopic Nasal Polyp Score.
- Trial name
- AirGOs-biol (NCT04823585)
- Testing
- Mepolizumab
- Where
- Finland
- Volunteers
- 95 people
- Sponsor
- Helsinki University Central Hospital
Nasal Polyps, Chronic Rhinosinusitis
A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to…
- Trial name
- POLYP 1 (NCT03280550)
- Testing
- Omalizumab
- Where
- 37 sites in United States, Canada and 8 more
- Volunteers
- 138 people
- Sponsor
- Hoffmann-La Roche
Sinusitis, Nasal Polyps
Comparison of Nasal Steroids After FESS in CRSwNP
The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal saline rinses in both the upright and head forward positions in patients who have had functional endoscopic sinus surgery (FESS) for…
- Trial name
- NCT02194062
- Testing
- fluticasone nasal spray, Budesonide head upright, Budesonide head forward
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Yale University
Chronic Sinusitis With Nasal Polyps and Eosinophilia
Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia
Phase 2, open-label, multi-center study to evaluate the clinical effects of oral administration of dexpramipexole for 6 months in subjects with chronic sinusitis with nasal polyps and eosinophilia.
- Trial name
- CS201 (NCT02217332)
- Testing
- dexpramipexole
- Where
- 7 sites in United States
- Volunteers
- 20 people
- Sponsor
- Knopp Biosciences