Aggravated airway inflammation: research on biological treatment (Mepolizumab) AirGOs-biologics

Helsinki University Hospital0 sites120 target enrollmentMarch 26, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: A triad of chronic rhinosinusitis with nasal polyps (CRSwNP), asthma and NSAID exacerbated respiratory disease (NERD)
Sponsor: Helsinki University Hospital
Enrollment: 120
Status: Active, Not Recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

March 26, 2020

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Helsinki University Hospital

•\-\=18 years of age
•\-chronic rhinosinusitis with bilateral polyps. Endoscopic bilateral nasal polyp score of at least 5 (out of 8\), with a minimum score of 2 in each nasal cavity
•\-SNOT\-22 \=25
•\-At least one other symptom, such as partial loss of smell (hyposmia), nasal obstruction, total loss of smell (anosmia), or anterior or posterior rhinorrhea
•\-\=1 previous CRS\-surgery. Note that the last CRS\-surgery must have been performed at least 6 months before 1st visit
•\-Peripheral blood eosinophils (PBEos) \>300 cells/ul at visit 1 OR (PBEos \>150 cells/ul at visit 1 AND a history of PBEos \>300 cells/ul during the past 12 months). A history of Nasal polyp tissue eosinophilia (NPeos) \=30% during the past 12 months is a supportive criterion.
•\-patient should have a history of at least one exacerbation during the past two years e.g. at least one criterion must be fulfilled of the following list during the past two years \=1 oral corticosteroids; \=3 antibiotic courses; \=1 CRS\-operation; \= 1 asthma hospitalization. In patients with contraindications of previously listed treatment or continuous oral steroids, additional criteria are not required.
•\-Asthma diagnosis (patient has the National Social Insurance Institution´s reimbursement right for asthma medication)
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•\-Age \<18 years
•\-CRS\-surgery \< 6 months before 1st visit
•\-pregnancy/ breastfeeding
•\-complication of CRS (f.ex. mucocele, invasive fungal rhinosinusitis). Take sinus CT scans, if needed!
•\-acute rhinosinusitis/respiratory infection
•\-severe disease related to airways/ immunology: cystic fibrosis, primary ciliary dyskinesia (PCD), sarcoidosis, immunosuppression, diagnosed Specific antibody deficiency (SAD), CVI, HIV, fungal rhinosinusitis; Young syndrome; Kartagener syndrome;
•\-other severe disease such as active cancer
•\-Received biologic therapy/systemic immunosuppressant/ASA desensitization therapy/experimental monoclonal antibody treatment to treat inflammatory or autoimmune disease within 2 months of study entry or 5 half\-lives, whichever is longer. The patient is allowed to use ASA dose \<100 mg/day due to cardiovascular reasons after ASA desensitization.
•\-current immunotherapy
•\-communication problems (f.e. neurological/psychiatric disease, language skills)