Clinical trials: Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)
PETRICHOR is a prospective, non-interventional, single-arm, multi-centre study in Germany evaluating real-world clinical and patient-reported outcomes in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP), whose…
- Trial name
- PETRICHOR (NCT07633158)
- Where
- 19 sites in Germany
- Volunteers
- 200 people
- Sponsor
- AstraZeneca
Chronic Rhinosinusitis With Nasal Polyps
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
EFC18418 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups.
- Trial name
- CEREN-1 (NCT06834347)
- Testing
- Itepekimab (SAR440340), Mometasone furoate nasal spray (MFNS)
- Where
- 121 sites in United States, Argentina and 19 more
- Volunteers
- 231 people
- Sponsor
- Sanofi
Chronic Rhinosinusitis With Nasal Polyps
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps
EFC18419 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups.
- Trial name
- CEREN-2 (NCT06834360)
- Testing
- Itepekimab (SAR440340), Mometasone furoate nasal spray (MFNS)
- Where
- 111 sites in United States, Argentina and 21 more
- Volunteers
- 216 people
- Sponsor
- Sanofi
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Nasal Polyps
Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis With Nasal Polyps
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous inflammatory disease of the sinonasal mucosa whose metabolic and immunologic mechanisms are incompletely understood.
- Trial name
- NCT07860411
- Testing
- Nasal polyp tissue and blood sampling, Nasal mucosa and blood sampling
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Harran University
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 Rhinosinusitis With Nasal Polyps
Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study
This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical…
- Trial name
- ENSEMBLE (NCT06914908)
- Testing
- Lunsekimig, Mometasone furoate nasal spray (MFNS)
- Where
- 24 sites in United States, Argentina and 4 more
- Volunteers
- 71 people
- Sponsor
- Sanofi
Chronic Rhinosinusitis With Nasal Polyps
An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps
This is a double-blind, parallel-group, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments.
- Trial name
- CEREN-3 (NCT07424144)
- Testing
- Itepekimab (SAR440340)
- Where
- 46 sites in United States, Argentina and 11 more
- Volunteers
- 59 people
- Sponsor
- Sanofi
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.
- Trial name
- NCT06338995
- Testing
- LY3650150, Standard therapy for INCS
- Where
- 202 sites in United States, Argentina and 18 more
- Volunteers
- 510 people
- Sponsor
- Eli Lilly and Company
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
NSAID-Induced Asthma, NSAIDs Hypersensitivity
Long-term Effect of Dupilumab in N-ERD
This prospective observational study investigates the long-term effects of Dupilumab in patients with NSAID-exacerbated respiratory disease (N-ERD).
- Conditions
- NSAID-Induced Asthma, NSAIDs Hypersensitivity, Chronic Rhinosinusitis (CRS), Asthma Bronchiale
- Trial name
- NCT07049978
- Testing
- Observational follow-up of standard Dupilumab treatment
- Where
- Austria
- Volunteers
- 15 people
- Sponsor
- Medical University of Vienna
Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Chitosan-Based, Gelatin Sponge and Non-absorbable Nasal Packing After Endoscopic Sinus Surgery
This single-centre prospective study compared three nasal packing materials used after endoscopic sinus surgery (ESS) in adults with chronic rhinosinusitis without nasal polyps: a chitosan-based bioresorbable pack (PosiSep X), an…
- Trial name
- ESSPACK-2024 (NCT07862283)
- Testing
- PosiSep X, Spongostan, Osseous polyvinyl alcohol sinus pack (EON Meditech)
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Sakarya University
Chronic Rhinosinusitis Without Nasal Polyps
A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
The primary purpose of the study is to evaluate the efficacy of brensocatib at 10 and 40 milligrams (mg) once daily (QD) compared with placebo in improving clinical symptoms of CRSsNP.
- Trial name
- BiRCh (NCT06013241)
- Testing
- Brensocatib, Mometasone furoate nasal spray (MFNS)
- Where
- 100 sites in United States, Argentina and 13 more
- Volunteers
- 288 people
- Sponsor
- Insmed Incorporated
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 With Nasal Polyps, Olfactory Disorder
Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis
The study aims to investigate the olfactory TDI score (Threshold, Discrimination, Identification) using the Sniffin' sticks test for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) on dupilumab.
- Trial name
- NCT04869436
- Testing
- Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Chronic Rhinosinusitis With Nasal Polyps
A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Participants With Chronic Rhinosinusitis With Nasal Polyps
The primary purpose of this study is to assess the effect of verekitug (UPB-101) on the endoscopically determined size and extend of nasal polyps in participants with chronic rhinosinusitis with nasal polyps (CRSwNP) and to…
- Trial name
- VIBRANT (NCT06164704)
- Testing
- Verekitug (UPB-101)
- Where
- 41 sites in United States, Czechia and 3 more
- Volunteers
- 81 people
- Sponsor
- Upstream Bio Inc.
Chronic Rhinosinusitis Without Nasal Polyps
Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps
This is a 12-Week randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of intranasal administration of 186 µg of OPN-375 twice a day (BID) in adolescent subjects with…
- Trial name
- Re-Open 3 (NCT06850805)
- Testing
- OPN-375
- Where
- 24 sites in United States
- Volunteers
- 84 people
- Sponsor
- Optinose US Inc.
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Asthma
ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia
ARES is a multi-centre, retrospective-prospective, non-comparative and non-interventional (observational) cohort study involving primary and secondary data collection within real-world settings of participants who have initiated…
- Trial name
- ARES (NCT07399665)
- Where
- 10 sites in Russia
- Volunteers
- 110 people
- Sponsor
- AstraZeneca
Chronic Rhinosinusitis With Nasal Polyps
Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis
The central hypothesis of this study is that the addition of dupilumab treatment onto standard-of-care intranasal corticosteroids will improve patient-reported measures of disease activity and sense of smell in a cohort of mostly…
- Trial name
- CRSwNP (NCT05246267)
- Testing
- Dupilumab
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Montefiore Medical Center
Olfactory Dysfunction, Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Neural Dissimilarity in Patients With Chronic Rhinosinusitis With Nasal Polyps Treated With Biologics
This project will focus on rehabilitation of olfactory dysfunction in patients with chronic rhinosinusitis with polyps given biological treatment based on functional magnetic resonance imaging.
- Conditions
- Olfactory Dysfunction, Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Functional Magnetic Resonance Imaging (fMRI)
- Trial name
- NCT07819162
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Chronic Rhinosinusitis With Nasal Polyps
Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS).
This randomized, controlled multicenter trial will recruit patients aged 18 to 70 years with recurrent nasal polyposis requiring surgery and indication for biologic treatment according to EPOS 2020 guideline.
- Trial name
- MELYSA (NCT07814924)
- Testing
- surgical arm, Mepolizumab 100 MG, combined arm
- Where
- 7 sites in Spain
- Volunteers
- 75 people
- Sponsor
- Instituto de Investigación Marqués de Valdecilla