Primary objective: to investigate the efficacy of Mepolizumab 100 milligram (mg) every month compared to placebo in reducing validated Sinonasal Outcome Test -22 score and on reducing endoscopic Nasal Polyp Score. The participants have a triad of chronic rhinosinusitis with nasal polyps (CRSwNP), asthma and non-steroidal anti-inflammatory drug exacerbated respiratory disease (NERD). The investigators will evaluate whether mepolizumab reduces the need for increased drug dosage (topical corticosteroid or bronchodilator dosage) and improves lung and nasal function more effectively than placebo. This first visit ensures the inclusion and exclusion criteria of the subject. If necessary, NERD will be verified by an ASA challenge test at a second additional visit. Participants have also 6 visits, on four of which subcutaneous injection of the study product is administered. During visits, a clinical examination, airway function tests, and nasal, blood, urine, and stool samples are also taken to elucidate predictive biomarkers of severely symptomatic NERD patients.
Primary objective: to investigate the efficacy of Mepolizumab 100 milligram (mg) every month compared to placebo in reducing validated Sinonasal Outcome Test -22 score and on reducing endoscopic Nasal Polyp Score. The participants have a triad of chronic rhinosinusitis with nasal polyps (CRSwNP), asthma and non-steroidal anti-inflammatory drug exacerbated respiratory disease (NERD). The investigators will evaluate whether mepolizumab reduces the need for increased drug dosage (topical corticosteroid or bronchodilator dosage) and improves lung and nasal function more effectively than placebo. This first visit ensures the inclusion and exclusion criteria of the subject. If necessary, NERD will be verified by an ASA challenge test at a second additional visit. Participants have also 6 visits, on four of which subcutaneous injection of the study product is administered. During visits, a clinical examination, airway function tests, and nasal, blood, urine, and stool samples are also taken to elucidate predictive biomarkers of severely symptomatic NERD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
95
Solution. Subcutaneous. Mepolizumab is a biological drug, a humanized monoclonal antibody against interleukin-5.
Solution. Subcutaneous.
Helsinki University Hospital
Helsinki, Finland
Change From Baseline at Week 16 in Sinonasal Outcome Test -22 (SNOT-22) Score
SNOT-22 is a validated symptom questionnaire. The score ranges between 0 and 110. A higher score means worse outcome.
Time frame: Baseline, Week 16
Change From Baseline at Week 16 in endoscopic Nasal polyp score of nasal cavity
Nasal polyp score is graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity. The score ranges between 0 and 110. A higher score means worse outcome.The Nasal polyp score FEV1% is measured by spirometry. A higher value means better lung function = better outcome.
Time frame: Baseline, Week 16
Change From Baseline at Week 16 in relative Forced expiatory volume in 1 second (FEV1 %) without bronchodilator.
FEV1% is measured by spirometry. It is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration, in relation to the validated national reference value of subjects with similar age, gender and height.
Time frame: Baseline, Week 16
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