This pilot study is a double-blinded, randomized controlled, two-centre trial in which subjects will receive 4 to 8 (subcutaneous administered) doses of medication (Omalizumab or placebo) (dose and dosing interval calculated on body weight and baseline total serum IgE). During the treatment period and follow-up, the clinical efficacy of the treatment will be assessed by evaluation of symptoms, Quality of Life questionnaire, morning Peak Expiratory Flow measurement, smell test, nasal endoscopy, CT-scan, peak nasal inspiratory flow and spirometry. Biological activity will be evaluated by measuring peripheral and local (in serum, in nasal secretions, biopsies) markers of inflammation. Study hypothesis 1. Evaluation of the efficacy and safety of anti-IgE (Omalizumab) in patients with nasal polyposis and comorbid asthma. 2. Exploration of anti-IgE effects on local and systemic metabolism of IgE in nasal polyposis 3. Clinical assessment of the IgE theory in the pathogenesis of nasal polyps
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
23
Omalizumab (Xolair(R)) is a recombinant DNA-derived humanized IgG1 monoclonal antibody that selectively binds to human IgE. Molecular weight is approximately 149 kilodaltons. Xolair(R) is a sterile, white, preservative-free, lyophilized powder contained in a single-use vial, reconstituted with Sterile Water For Injection (SWFI), and administered as subcutaneous (SC) injection. Xolair(R) will be administered subcutaneously in a dose of 75 to 375mg every 2 to 4 weeks. Doses (mg) and dosing frequency are determined by total serum IgE level (IU/ml) measured at the start of treatment and body weight (kg). During this 20-week during trial patients will receive 4 or 8 doses of omalizumab.
Placebo
University Hospital, Ghent
Ghent, Belgium
UZ Gasthuisberg
Leuven, Belgium
Effect of Omalizumab on nasal polyp size and evolution of nasal polyps
Nasal examination at all visits by endoscopy of each nasal fossa. Polyps will be graded by the Modified DAVOS score
Time frame: At every study visit starting from week 0 until week 20
Effect of Omalizumab on rhinosinusitis symptoms:nasal discharge, nasal congestion, postnasal drip scores: Subject's Diary
Dispense / collect / review diary
Time frame: At screening visit, baseline visit and at week 0, 4, 8, 12, 16, 20
Effect of Omalizumab on asthma symptom scores including cough, wheeze, dyspnoea: Subject's Diary.
Dispense / collect / review diary
Time frame: At screening visit, baseline visit and at week 0, 4, 8, 12, 16, 20
Effect of Omalizumab on sinus computed tomography (CT)-scan score : Sinus CT-scan evaluation
Sinus CT-scan evaluation
Time frame: Visit before dosing and at week 16
Effect of Omalizumab on smell: UPSIT (University of Pennsylvania Smell Identification Test)
Olfactory test
Time frame: Baseline visit and at week 10
Effect of Omalizumab on Rhinitis specific Quality of Life: Rhinosinusitis Outcome Measure (RSOM-31)
Time frame: At baseline visit
Effect of Omalizumab on asthma related Quality of life: Asthma Quality of Life Questionnaire (AQLQ)
Time frame: At baseline visit
Effect of Omalizumab on overall Quality of Life: The Short Form (36) Health Survey (SF-36)
Time frame: At baseline visit
Effect of Omalizumab on peak nasal inspiratory flow
Time frame: On screening visit, baseline visit and on week 4,8,12, 16 and 20
Effect of Omalizumab and Forced Expiratory Volume in 1 second (FEV1): spirometry
Time frame: At screening visit, baseline visit and week 16 and 20
Effect of Omalizumab on diverse inflammatory mediators in serum, in nasal fluid (eosinophilic cationic protein (ECP), Interleukin-2 receptor (IL-2R), Sol Interleukin-5 receptor, soluble Cluster of differentiation 23 (sCD23), tryptase)
Time frame: At screening visit, baseline visit and week 4, 8, 12, 16 and 20
Evaluation of adverse events, directly or by general physical examination, blood sampling , review of concomitant medication or symptom scores.
Time frame: week 2, 4, 6, 8, 10, 12, 14, 16, 20
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