Phase II Efficacy Study of Aerosolized Recombinant Human IL-4 Receptor in Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Change from baseline in Forced expiratory volume in 1 second (FEV1)
研究概览
简要总结
The purpose is to measure the effectiveness of recombinant human interleukin-4 receptor (IL-4R) in treating asthma.
Asthma can be caused by the allergic response from breathing in certain irritants. Interleukin 4 (IL-4), which is naturally produced by the body, plays a major role in this allergic response. Doctors feel that IL-4 activity may be stopped by giving IL-4R, a product that binds to IL-4, and thereby decrease the problems of asthma.
详细描述
A major factor in the pathogenesis of asthma is the development of an allergic inflammatory response to inhaled antigens. Interleukin-4 (IL-4) plays a key role in this response. Binding and inactivating the IL-4 molecule with IL-4R may diminish the allergic asthmatic response by inhibiting activities of IL-4.
Patients are randomized to 1 of 3 treatment groups and, within each group, are stratified by baseline FEV1 cohort. Patients receive either dose level 1 of IL-4R, dose level 2 of IL-4R, or placebo, by aerosol drug delivery device, once a week for 12 weeks. There are frequent clinic visits and several follow-up visits. Physical exams and spirometry are done regularly; immunizations are administered on Day 28; and a skin tests panel is given on Day 84. Blood samples are collected at study visits during treatment and follow-up to test for immunology/serology parameters, chemistry profiles, and asthma-related DNA polymorphisms. Patients are provided with peak flow meters and must demonstrate their proper use so that a peak expiratory flow (PEF) diary and a symptoms diary can be maintained. Selected sites measure exhaled nitric oxide and collect induced sputum samples. Assessments for adverse events are conducted at 16 and 40 weeks following the first study drug treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients may be eligible for this study if they:
- •Are 12 to 85 years of age (consent of parent or guardian required if under 18 years).
- •Have continuous asthma and are being treated with albuterol MDI only.
- •Have reduced lung functions.
- •Have a positive reaction to 2 substances as demonstrated with a skin test.
- •Have been a nonsmoker for at least 2 years and have not smoked more than 1 pack a day for 5 years or less.
- •Agree to use contraception throughout the study.
- •Agree not to donate blood throughout the study.
- •Are able to use correctly an aerosol drug delivery device.
- •Have had an asthma attack on at least 3 of the last 7 days.
排除标准
- •Patients will not be eligible for this study if they:
- •Had asthma requiring hospitalization within 6 weeks of beginning study treatment.
- •Had asthma requiring emergency room treatment within 12 months of beginning study treatment.
- •Had a respiratory infection that affected asthma within 2 weeks of beginning study treatment.
- •Had a breathing tube inserted for asthma treatment within 15 years of beginning study treatment.
- •Were previously enrolled in a study of soluble IL-4 receptor.
- •Have drug abuse, alcohol abuse, or a mental illness that may interfere with the study.
- •Have serious medical problems (such as heart or lung problems, uncontrolled high blood pressure, are overweight to the extent that ability to breathe is affected, or have cancer other than skin cancer), diabetes, autoimmune diseases, or HIV.
- •Are pregnant or breast-feeding.
- •Have used certain drugs.
研究组 & 干预措施
0.75mg rsIL-4R
Recombinant human soluble IL-4 receptor (rsIL-4R) given by means of inhalation once weekly for 12 weeks. The study drug was administered in the clinic at a final volume of 2.5 mL in sterile normal saline solution with a breath-assisted Pari LC Star nebulizer powered by a Proneb Turbo portable compressor.
干预措施: Recombinant human soluble IL-4 receptor (Biological)
1.5mg rsIL-4R
Recombinant human soluble IL-4 receptor (rsIL-4R) given by means of inhalation once weekly for 12 weeks. The study drug was administered in the clinic at a final volume of 2.5 mL in sterile normal saline solution with a breath-assisted Pari LC Star nebulizer powered by a Proneb Turbo portable compressor.
干预措施: Recombinant human soluble IL-4 receptor (Biological)
3.0mg rsIL-4R
Recombinant human soluble IL-4 receptor (rsIL-4R) given by means of inhalation once weekly for 12 weeks. The study drug was administered in the clinic at a final volume of 2.5 mL in sterile normal saline solution with a breath-assisted Pari LC Star nebulizer powered by a Proneb Turbo portable compressor.
干预措施: Recombinant human soluble IL-4 receptor (Biological)
Placebo for rsIL-4R
The placebo for recombinant human soluble IL-4 receptor (rsIL-4R) consisted of identically prepared excipient in the same volume (2.5 mL). To maintain blinding, medication was dispensed by an individual who was not responsible for patient care or assessment. Treatment assignment was blinded to all personnel involved in direct conduct or monitoring of the study.
干预措施: Placebo for Recombinant human soluble IL-4 receptor (Biological)
结局指标
主要结局
Change from baseline in Forced expiratory volume in 1 second (FEV1)
时间窗: 3 months
次要结局
未报告次要终点