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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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⁃ 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

Locations
Other Locations
Belgium
Ghent University Hospital
RECRUITING
Ghent
Contact Information
Primary
Manon Blauwblomme, Masters
manon.blauwblomme@ugent.be
+32 09 332 23 98
Backup
Philippe Gevaert, Prof. Dr.
Time Frame
Start Date: 2022-03-01
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 180
Sponsors
Leads: University Hospital, Ghent

This content was sourced from clinicaltrials.gov