NCT00987909已完成2 期
A Phase II Trial Assessing the Tolerability and Pharmacodynamic Effect of US SLIT Cat Hair in Subject With Cat Allergy and Investigating Efficacy Variables in an Environmental Exposure Chamber Model
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
The main purpose of this trial is to investigate if any of three different doses of cat hair immunotherapy is safe for treatment of cat allergic patients.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of rhinoconjunctivitis on exposure to cats
- •Positive Skin Prick Test response (wheal diameter at least 3 mm larger than the negative control
- •Positive specific IgE against Fel d1 (at least IgE Class 2)
- •Minimum qualifying rhinoconjunctivitis symptom score during EEC exposure at Visit 2
排除标准
- •Uncontrolled asthma within the past 12 months, or asthma requiring regular use of inhaled corticosteroids
- •FEV1 less than 80% of predicted
- •Subjects who suffer from significant seasonal allergic rhinoconjunctivitis, and cannot complete the clinical trial outside the local pollen season, or who have significant allergy to other allergens (e.g. other animals or house dust mites) that cannot be avoided during the trial period
- •Subjects who cannot tolerate baseline challenge in the Environmental Exposure Chamber
- •History of anaphylaxis with cardio/respiratory symptoms
- •A medical history of severe drug or food allergy with symptoms such as difficulty breathing, swelling of the face or a feeling of severe dizziness or increased heart rate
- •Chronic urticaria
- •History of severe cardiac disease
- •Treatment with immunosuppressives, anti-IgE monoclonal antibodies, tricyclic antidepressants or MAOIs
结局指标
主要结局
Adverse Events
时间窗: During 16 weeks of treatment
次要结局
- Rhinoconjunctivitis symptom score(After 0, 8, and 16 weeks of treatment)
- Overall rhinoconjunctivitis symptom score(After 0, 8, and 16 weeks of treatment)
- Acoustic Rhinometry(After 0, 8, and 16 weeks of treatment)
- Environmental Exposure Chamber Quality of Life(After 0, 8, and 16 weeks of treatment)
- Serum immunology(After 0, 8, and 16 weeks of treatment)
- Nasal secretion immunology(After 0 and 16 weeks of treatment)
- Safety lab testing (clinical chemistry, haematology, urinalysis)(After 0 and 16 weeks of treatment)
研究者
研究点 (2)
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