Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polypos… (NCT01393340) | Clinical Trial Compass
CompletedPhase 2
Clinical and Biological Effects of Anti-IgE (Omalizumab) in Patients With Bilateral Nasal Polyposis and Asthma
Belgium23 participantsStarted 2006-12
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects must be at least 18 years of age, of either gender and any race.
* Subjects must have a diagnosis of bilateral nasal polyps at screening and baseline that have recurred after surgical resection or nasal polyps that are grades 3 or 4 in both nares using the scoring system described in table 5. Bilateral nasal polyposis is defined as sinus symptoms for more than 3 months, bilateral opacity on CT-scan imaging and visible nasal polyps at endoscopy.
Subjects must have a diagnosis of asthma for more than 2 years. Subjects must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety.
* Subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.
* Subjects must be free of any upper respiratory tract infection within two weeks prior to inclusion.
* Clinical laboratory tests must be within normal limits or clinically acceptable for the investigator.
* Non-pregnant women of childbearing potential must use a medically acceptable, adequate form of birth control. This includes: a) hormonal contraceptive as prescribed by a physician (eg, oral combined, hormonal implant, depot injectable); b) medically prescribed Intra-Uterine Device (IUD); c) condom in combination with a spermicide; d) monogamous relationship with a male partner who has had a vasectomy or is using a condom plus …
What they're measuring
1
Effect of Omalizumab on nasal polyp size and evolution of nasal polyps
Timeframe: At every study visit starting from week 0 until week 20