NL-OMON33750已完成4 期
An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis - none
Harrison Clinical Research Benelux0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 99（—）
入选标准
- •1. Males/females age >= 12 years
- •2. Cystic Fibrosis diagnosed by either gene profiling and/or sweat test
- •3. ABPA previously diagnosed according to the Cystic Fibrosis Foundation Consensus
- •Conference recommendations - minimal diagnostic criteria for diagnosis of ABPA in
- •cystic fibrosis (Stevens et al, 2003) defined as:
- •i) Acute or sub-acute clinical deterioration (cough, wheeze, exercise intolerance,
- •exercise-induced asthma, change in pulmonary function, or increased sputum
- •production) not attributable to another etiology.
- •ii) Total serum IgE concentration of >500 IU/mL (1200 ng/mL).
- •iii) Immediate cutaneous reactivity to Aspergillus (prick skin test wheal >3mm in
- •diameter with surrounding erythema, while the patient is not being treated with
- •systemic antihistamines) or in vitro demonstration of IgE antibody to A.fumigatus.
- •iv) One of the following:
- •a)precipitans to A.fumigatus or in vitro demonstration of IgG antibody to A.fumigatus
- •b)new or recent abnormalities on chest radiography (infiltrates or mucus plugging)
- •or chest CT (bronchiectasis) that has not cleared with antibiotics and standard
- •physiotherapy.
- •3. Total serum IgE level of > 500 IU/ml (will be measured locally at Screening Visit).
- •Screening IgE levels will determine the dose throughout the study.
- •4. Patients who are being treated for ABPA by any oral corticosteroid (for at least 8 weeks
- •prior to the first dose of study treatment - with an OCS entry dose of minimum
- •5mg/maximum 40mg per day in prednisolone equivalence). Patients must have a history
- •of at least one unsuccessful attempt to taper steroids defined as in the clinician*s
- •judgment, an ABPA exacerbation during taper (chronic ABPA group)
- •Patients who present with an acute episode of ABPA, either as a first presentation or as a
- •recurrence, and who were taking a maximum dose of prednisolone of 20mg/day (or
- •equivalent) prior to the ABPA flare (acute ABPA group)
- •5. Patients must have an FEV1, as measured at the Baseline Visit, of no lower than 90% of
- •their previous best FEV1 as measured at Screening Visit
- •6. FEV1 >40% of predicted in patients aged < 16 years old, and FEV1 of >30% of predicted
- •is acceptable in patients aged >= 16 years old as measured after 12 hour washout of LABA
- •\ 6 hours of SABA
- •7. Female subjects of childbearing potential must be advised that systemic corticosteroids
- •pose a known risk to mother and fetus. Xolair is FDA pregnancy category B. This
- •medication is not expected to be harmful to an unborn. However, patients are advised to
- •use adequate methods of contraception, (e.g. hormonal contraceptive plus condom, intrauterine
- •device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.),
- •from the time of screening and for the duration of the study, through study completion.
- •Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods)
- •and withdrawal are not adequate methods of contraception
- •8. Female subjects who report surgical sterilization must have had the procedure at least six
- •(6) months prior to initial dosing. Surgical sterilization procedures should be supported
- •with clinical documentation made available to the sponsor and noted in the Relevant
- •Medical History / Current Medical Conditions section of the CRF
- •9. Postmenopausal females must have had no regular menstrual
排除标准
- •1. History of cancer in the past 10 years (except surgically-cured basal cell or squamous cell skin cancer).
- •2. Any previous history of anaphylaxis.
- •3. Any other medical condition that in the opinion of the investigator may cause the patient
- •to be unsuitable for completion of the study or place the patient at potential risk from
- •being in the study.
- •4. Pregnant women.
- •5. Prior Xolair exposure.
- •6. Lung or other transplant.
- •7. Participation in any clinical trial within four (4) weeks prior to initial dosing or longer if
- •required by local regulations, and for any other limitation of participation based on local
- •regulations.
- •8. Hemoglobin levels below 10.0 g/dl at screening.
- •9. History of immunodeficiency diseases.
- •10. Significant illness other than CF/ABPA within two (2) weeks prior to initial dosing.
- •11. A past medical history of clinically significant ECG abnormalities.
- •12. Patients who are known to be positive for chronic atypical Mycobacteria and Burkholderia
- •cepacia including subspecies.
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