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

Phase 1

• Conditions: A triad of chronic rhinosinusitis with nasal polyps (CRSwNP), asthma and NSAID exacerbated respiratory disease (NERD); Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2020-000421-76-FI
• Lead Sponsor: Helsinki University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-26
• Last Update Posted: 29 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

-=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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-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)
-unlikely to comply
-ASA-challenge negative.
-History of hypersensitivity to mepolizumab or excipients in the formulation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified