Double Blind Placebo Controlled Study to Assess the Expression of IgE on Basophils and Dendritic Cells During Omalizumab Treatment.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo
研究概览
简要总结
The aim of this study is to evaluate the expression of IgE high affinity receptors (the part of the cell associated with allergic response) in patients suffering from uncontrolled severe asthma despite long term treatment with high dose of inhaled corticosteroid and long acting Beta-2 agonist.
详细描述
Double blind placebo controlled study to assess the expression of IgE on blood basophils and dendritic cells in patients with uncontrolled, severe, persistent allergic asthma after a 16-week Omalizumab 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged >= 18 years.
- •Patients with severe persistent allergic asthma with the following characteristics:
- •FEV1 (Forced Expiratory Volume in One Second) <80% of predicted.
- •Frequent daily symptoms (>=4 days/week on average) or nocturnal awakening (>=1/week on average).
- •Multiple severe asthma exacerbations: either >=2 severe asthma exacerbations having required an unscheduled medical intervention with systemic corticosteroid in the past year, or hospitalization (including emergency room treatment) for an asthma exacerbation in the past year.
- •Despite a high dose inhaled corticosteroid >1000 mg beclomethasone dipropionate or equivalent and a inhaled long-acting B2-agonist.
- •With an allergy to a perennial allergen demonstrated with convincing criteria, i.e. positive prick skin test or in vitro reactivity to a perennial aeroallergen (RAST).
- •Total serum IgE level >= 30 to <=700 IU/ml and suitable serum total IgE level and weight according to Xolair dosing tablets.
排除标准
- •Age < 18 years.
- •Smoking history > 20 pack years.
- •Patients who have had an asthma exacerbation during the 4 weeks prior to randomization
- •History of food or drug related severe anaphylactoid or anaphylactic reaction
- •Elevated serum IgE levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis).
- •Patients with active cancer, suspicion of cancer or any history of cancer.
- •Pregnant women.
- •Known hypersensitivity to omalizumab or to one of its components.
- •Patients already treated with omalizumab (indeed a previous treatment with omalizumab could have modified the FceRI expression).
- •Patients who had participated in a clinical trial in the past 3 months.
研究组 & 干预措施
Omalizumab
Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
干预措施: Omalizumab (Drug)
Placebo
Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo
时间窗: Baseline and Week 16
Blood was drawn from participants at baseline and at Week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value.
Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo
时间窗: Baseline and Week 16
Blood was drawn from participants at baseline and at week 16. Basophils and dendritic cells expressing FcεRI were counted and the percentage was calculated. Fluorescence was used to label FcεRI so that they could be visualized. The greater the fluorescence intensity the greater FcεRI expression. The change from baseline is described by the difference (%) between the baseline value, before the first study drug administration, and the value observed at the end of study, expressed as a percent of the baseline value.
次要结局
- Change (%) From Baseline in Percent of Basophils and Dendritic Cells Expressing FcεRI After 4, 8, 12 and 16 Weeks of Treatment(Baseline, Weeks 4, 8, 12 and 16)
- Change (%) From Baseline in the Mean Fluorescence Intensity of FcεRI After 4, 8, 12 and 16 Weeks of Treatment(Baseline, Weeks 4, 8, 12, and 16)
- Change From Baseline in the Number of Days With Asthma Symptoms Per Week(Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16))
- Change From Baseline in the Number of Puffs of Rescue Medication Per Week(Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16))
- Change From Baseline in the Number of Nights With Awakenings Per Week(Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16))
- Change From Baseline in the Number of Days With Impairment in Daily Activities Per Week(Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16))
- Change From Baseline in the Number of Days With Absence From School or Work Due to Asthma Symptoms(Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16))
- Change From Baseline in the Number of Days With Hospitalizations(Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16))
- Change From Baseline in the Number of Unscheduled Clinic Visits(Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16))
- Change From Baseline in the Morning Daily Peak Expiratory Flow (PEF)(Baseline (the 4 week screening period prior to randomization) and End of Study (Weeks 12 - 16))
- Physician's Overall Assessment of Treatment Effectiveness(After 16 weeks of treatment)