A triad of chronic rhinosinusitis with nasal polyps (CRSwNP), asthma and NSAID exacerbated respiratory disease (NERD)
Conditions
Interventions
Trade Name: Nucala 100mg/dose, injection, R03DX09
Product Name: Nucala
Product Code: R03DX09
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the
Sponsors
Helsinki University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to evaluate the effect of Mepolizumab on CRSwNP, asthma and NERD. ;Secondary Objective: ;Primary end point(s): Primary: nasal polyp score and SNOT22 symptom score, VAS score (of smell loss, obstruction, postnasal drip, nasal discharge, facial pain/pressure) and, exacerbation-rate. Exacerbation means that patient has at least one of the following due to airway symptoms: oral corticosteroid course; antibiotic courses; sinus lavation; hospitalization. ;Timepoint(s) of evaluation of this end point: -1, 0, 1, 2, 3, 4, 5 months after start of IMP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): other medication such as dosing-up medication, and medication of exacerbations (antibiotics, bronchodilators, nasal decongestants, systemic corticosteroids) BEos, NPeos signs of Type2-inflammation in blood and nasal samples nasal and lung function test results (FEV1, peak expiratory flow rate, eNO, nNO and/or MCA in Acoustic rhinometry, PNIF, Sniffin’ sticks 12) Number of patients who met criteria for requiring surgery for polyposis at each time point Questionnaire-packet: 15D, mini-AQLQ, Asthma control test, iMCQ, iPCQ, WPAI, EQ-5D-5L Consideration/planning of a CRS-operation due to airway symptoms Cost-effect and productivity (iMCQ,iPCQ questionnaires, sick leaves due to airway symptoms) Safety (adverse effects) The following clinical data are also collected: Lund-Mackay score of Sinus CT scans/Cone beam CT, performed 12 months prior to the study. Questions concerning uncontrolled CRS according to EPOS12 and EPOS20 -criteria;Timepoint(s) of evaluation of this end point: -1, 0, 1, 2, 3, 4, 5 months after start of IMP. | — |
Countries
Finland
Contacts
Public ContactSanna Toppila-Salmi
Helsinki University Hospital
Outcome results
None listed