Clinical trials: Chronic Rhinosinusitis
Chronic Sinusitis
A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis
The purpose of this study is to assess the safety and performance of the Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Rhinosinusitis.
- Trial name
- CONSENSUS II (NCT00840970)
- Testing
- non-coated Intranasal Splint, Sinexus Intranasal Splint
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Intersect ENT
Chronic Sinusitis With or Without Nasal Polyps
Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps
This is an open-label, multicenter study designed to assess the safety of intranasal administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose device in subjects with chronic sinusitis with or…
- Trial name
- NCT01623323
- Testing
- Fluticasone Propionate
- Where
- 18 sites in United States
- Volunteers
- 705 people
- Sponsor
- Optinose US Inc.
Chronic Sinusitis Without Nasal Polyps
A Study to Evaluate the Efficacy and Safety of HTMC0658 Tablets in the Treatment of Chronic Rhinosinusitis Without Nasal Polyps
The purpose of this clinical trial is to assess the efficacy and safety of HTMC0658 tablets in treating subjects with chronic rhinosinusitis without nasal polyps (CRSsNP).
- Trial name
- NCT07174115
- Testing
- HTMC0658
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Chronic Rhinosinusitis with Nasal Polyps
The Study of GR1802 in Patients with Chronic Rhinosinusitis with Nasal Polyps
This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of GR1802 injection in comparison to placebo in addition to a background treatment of…
- Trial name
- NCT05873803
- Testing
- GR1802 injection
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Chronic Rhinosinusitis With Nasal Polyps
A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With Tezepelumab
This is a multicentre, open-label, single-arm, Phase 3b study to assess nasal polyps score and symptoms in Chinese adult participants with chronic rhinosinusitis with nasal polyposis initiating treatment with tezepelumab.
- Trial name
- BIFANG (NCT07520162)
- Testing
- Tezepelumab
- Where
- 34 sites in China
- Volunteers
- 230 people
- Sponsor
- AstraZeneca
Chronic Sinusitis
Amphotericin B Suspension in Refractory Chronic Sinusitis
The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with…
- Trial name
- NCT00425620
- Testing
- SinuNase
- Where
- 68 sites in United States
- Volunteers
- 300 people
- Sponsor
- Accentia Biopharmaceuticals
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 Sinusitis, Chronic Rhinosinusitis (Diagnosis)
Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults
Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.
- Trial name
- ENLIGHTEN 1 (NCT05219968)
- Testing
- LYR-210, Background Therapy
- Where
- 55 sites in United States, Austria and 3 more
- Volunteers
- 196 people
- Sponsor
- Lyra Therapeutics
Acute Rhinosinusitis, Recurrent Acute Rhinosinusitis
NAC Inhalation in the Treatment Of Symptomatic acuTe rhinosinUSitis
N-acetylcysteine (NAC), known to have mucolytic and antioxidant effects, is widely used to treat respiratory diseases and manage post-surgery pulmonary complications.
- Conditions
- Acute Rhinosinusitis, Recurrent Acute Rhinosinusitis, Chronic Rhinosinusitis
- Trial name
- NOTUS (NCT04131686)
- Where
- South Korea
- Volunteers
- 294 people
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Chronic Sinusitis, Nasal Polyposis
Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE)
The ENCORE Study is designed to evaluate the repeat administration of the S8 Sinus Implant in chronic sinusitis (CS) patients with recurrent nasal polyps.
- Trial name
- NCT03358329
- Testing
- S8 Sinus Implant
- Where
- 9 sites in United States
- Volunteers
- 50 people
- Sponsor
- Intersect ENT
Chronic Sinusitis
Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat 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…
- Trial name
- NCT04163978
- Testing
- Nitric Oxide, Budesonide
- Where
- Canada
- Volunteers
- 56 people
- Sponsor
- Sanotize Research and Development corp.
Chronic Rhinosinusitis With Nasal Polyps
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
The main objective of this study is to evaluate treatment outcomes of tezepelumab among participants with physician-determined surgery-eligible CRSwNP, with or without asthma. Study details include: 1.
- Trial name
- ESSENCE (NCT06706817)
- Testing
- Tezepelumab
- Where
- 41 sites in United States, Bulgaria and 7 more
- Volunteers
- 181 people
- Sponsor
- AstraZeneca
Chronic Rhinosinusitis With Nasal Polyps
Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52)
This was a Phase 4, open-label, single-arm, multicenter study to evaluate the efficacy and safety of dupilumab subcutaneous (SC) injection monotherapy in Japanese participants aged 18 or older with CRSwNP that is not adequately…
- Trial name
- NCT05049122
- Testing
- Dupilumab SAR231893
- Where
- Japan
- Volunteers
- 25 people
- Sponsor
- Sanofi
Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
This study will assess the safety, tolerability, pharmacokinetics and efficacy of two LYR-220 designs in symptomatic adult chronic rhinosinusitis (CRS) subjects who have had a prior functional endoscopic sinus surgery.
- Trial name
- NCT05035654
- Testing
- LYR-220 Design 1 (Part 1 only), LYR-220 Design 2 (Part 1 and Part 2)
- Where
- 25 sites in United States, Australia
- Volunteers
- 48 people
- Sponsor
- Lyra Therapeutics
Chronic Rhinosinusitis
Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Rhinosinusitis 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
- NCT03960580
- Testing
- OPN-375
- Where
- 87 sites in United States, Australia and 8 more
- Volunteers
- 223 people
- Sponsor
- Optinose US Inc.
Chronic Rhinosinusitis With Nasal Polyps
A Study to Investigate the Clinical Outcome and Quality of Life in Chinese Post-operative CRSwNP Patients
This is a prospective, multicenter real-world observational study designed to describe post-operative outcomes, quality of life, disease control, recurrence-related characteristics, economic burden and post-operative treatment…
- Trial name
- PREDICT (NCT07446738)
- Testing
- Other: Routine Clinical Care for CRSwNP
- Where
- 21 sites in China
- Volunteers
- 146 people
- Sponsor
- AstraZeneca
Chronic Rhinosinusitis (Diagnosis)
Real-Life Chronic Rhinosinusitis Outcome Registry
An international consortium of leading medical experts in the field of chronic respiratory disease, the research team of Galenus Health and the non-profit organization EUFOREA (European Forum for Research and Education in Allergy…
- Trial name
- NCT04670172
- Where
- 13 sites in Austria, Belgium and 8 more
- Volunteers
- 4,550 people
- Sponsor
- Change Accelerator in Respiratory Care
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
Sinusitis, Chronic Rhinosinusitis
Clinical Evaluation of the Ethmoid Sinus Spacer
Evaluation of treatment of the ethmoid sinuses with the Ethmoid Sinus Spacer and Access system
- Trial name
- SPACER (NCT01054703)
- Testing
- Ethmoid Sinus Spacer
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Integra LifeSciences Corporation
Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP), Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
GB001 in Adult Participants With Chronic Rhinosinusitis
A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GB001 compared with placebo over 16 weeks of treatment in patients…
- Trial name
- NCT03956862
- Testing
- GB001
- Where
- 38 sites in United States, Czechia and 1 more
- Volunteers
- 97 people
- Sponsor
- GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.