Asthma Clinical Trial
Official title:
Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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