Long-term study of biological medicines in adults with severe nasal polyps
Observes long-term results of mepolizumab in adults with chronic nasal polyps, with or without asthma.
Plain-language title generated from the registry record
Registry title: Real Life Study of Biologicals in Patients With Severe CRSwNP
Key facts
- Where
- Ghent, BelgiumSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05938972, who can take part
Where in Belgium
- Ghent university hospitalGhent, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Ghent
- Trial code
- NCT05938972
- Record updated
- 15 April 2024
- Original description
This study is a pragmatic, real-life, observational study recruiting adult patients with chronic rhinosinusitis with nasal polyposis who are eligible to start biologicals as standard treatment. The aim of this study is to observe the long-term outcomes of biologicals in CRSwNP patients with or without comorbid asthma in 'real life'. Moreover, the investigators will gain insight into the mechanisms of biologicals in the local and systemic immunity of these patients and investigate novel local and systemic biomarkers and predictors of response.Read full original descriptionShow less
Real Life Study Assessing Long Term Outcomes and Predictive Factors of Response to Biologicals in Patients With Severe CRSwNP and/or Severe Allergic and/or Eosinophilic Asthma
This study is a pragmatic, real-life, observational study recruiting adult patients with chronic rhinosinusitis with nasal polyposis who are eligible to start biologicals as standard treatment. The aim of this study is to observe the long-term outcomes of biologicals in CRSwNP patients with or without comorbid asthma in 'real life'. Moreover, the investigators will gain insight into the mechanisms of biologicals in the local and systemic immunity of these patients and investigate novel local and systemic biomarkers and predictors of response.
Inclusion: Patients must meet the following criteria to be eligible for the enrolment in the study:; Signed informed consent form (ICF),; Age between 18 and 80 years at time of signing ICF,; Able to comply with the study protocol, in the investigator's judgment,; In group one: patients with severe allergic and/or eosinophilic asthma, defined by being currently treated with a biological (SoC) OR starting treatment with a biological (SoC); In group two: patients with CRSwNP with or without asthma, defined by starting treatment with a biological (SoC) and fulfill the criteria for reimbursement of a biological therapy.
Exclusion: Patients who do not meet the reimbursement criteria of a biological therapy cannot participate in the study.