EUCTR2006-003524-11-BE进行中（未招募）不适用
Clinical and biological effects of Anti-IgE (Omalizumab) in patients with bilateral nasal polyposis and asthma
niversity Hospital Gent0 个研究点开始时间: 2006年8月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a. Subjects must be at least 18 years of age, of either gender and any race.
- •b. 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.
- •c. Subjects must have a diagnosis of asthma for more than 2 years.
- •d. 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.
- •e. Subjects must be willing to give informed consent and adhere to visit schedules, medication restrictions, and agree to perform daily diary entries.
- •f. Subjects must be free of any upper respiratory tract infection within two weeks prior to inclusion.
- •g. Clinical laboratory tests must be within normal limits or clinically acceptable for the investigator.
- •h. 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 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 spermicide during the study. They must have started this birth control method at least three months prior to screening (with the exception of condom in combination with a spermicide), and they must agree to continue its use for at least 3 months after last dosing. Women of childbearing potential who are not currently sexually active must agree and consent to using a double-barrier method should they become sexually active during the course of this study. Women who are surgically sterilized or are at least one year postmenopausal are considered not to be of childbearing potential. However, all female subjects must have a urine pregnancy test prior to treatment, which must be negative. A monthly-control pregnancy test is requested.
- •i. Male subjects must agree to use an adequate form of birth control from first dosing to at least 3 months after last dosing. They must either agree to use a condom with spermicide or agree to have sexual relations only with women using medically acceptable forms of birth control as described above.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a. Women must not be pregnant, breast feeding, or premenarcheal.
- •b. Patients younger than 18 years old.
- •c. Subjects with history of systemic reactions to the study medication.
- •d. Subjects with prohibited medication at screening without full wash-out period.
- •e. Subjects with acute sinusitis, concurrent nasal infection, or subjects who have had a nasal or upper respiratory tract infection within two weeks of the inclusion are excluded.
- •f. Subjects with cystic fibrosis, primary ciliary’s dysfunction or Kartagener’s syndrome by history are excluded.
- •g. Subjects must not have ever been diagnosed with a parasitic infection.
- •h. Subjects must not have ever been diagnosed with cancer
- •i. Subjects must not have a medical history of HIV or hepatitis B or C. Testing will not be done at screening.
- •j. Subjects must not have had an acute asthmatic attack requiring admission to a hospital (excluding emergency room visits which resulted in direct discharge without hospitalization) within the four weeks prior to screening.
- •k. Subjects must not have received specific immunotherapy within the previous three months.
研究者
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