A Randomized, Double-blind, Placebo-controlled Study to Demonstrate the Efficacy of Xolair in an Allergen Bronchoprovocation Study in Asthmatic Populations Defined by Serum IgE Concentrations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients
研究概览
简要总结
This study was intended to demonstrate that patients with standard and high immunoglobulin E (IgE) levels can be protected from allergen induced broncho-constriction by Xolair
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male and female adult patients, body weight between 40-150 kg aged 18-65 years (inclusive)
- •Patients diagnosed with asthma with Forced Expiratory Volume (FEV1) ≥65% of the predicted normal value for the patient
- •Positive skin prick test to a specific allergen
- •Patients had to demonstrate a Provocative Dose 20% FEV1 decline (PD20) response to an aeroallergen in the graded allergen bronchoprovocation testing (ABP) at screening
排除标准
- •Current active smokers
- •Patients who have been hospitalized or had emergency treatment for an asthma attack in the 12 months prior to study start
- •History of bleeding disorders
- •History of drug allergy
- •Pregnant women or nursing mothers
- •Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).
- •Sexually active males who have not been sterilized and are not using a condom
- •History of immunocompromise, including a positive HIV
- •A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •History of drug or alcohol abuse within 12 months of study start
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL)
Patients with screening Immunoglobulin E (IgE) levels = 30-300 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
干预措施: Xolair (Drug)
Xolair (Immunoglobulin E (IgE) = 700-2000 IU/mL)
Patients with screening Immunoglobulin E (IgE) levels = 700- 2000 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
干预措施: Xolair (Drug)
Xolair (Immunoglobulin E (IgE) = 301-699 IU/mL)
Patients with screening Immunoglobulin E (IgE) levels = 301- 699 IU/mL. Participants received subcutaneous injections of Xolair (Omalizumab) every 2 weeks; dosage dependent on IgE level and body weight.
干预措施: Xolair (Drug)
Placebo
By subcutaneous injection of a solution with a concentration of 125 mg/mL placebo in a supine position: Patients in Xolair (Immunoglobulin E (IgE) = 30-300 IU/mL) group received doses of 150 mg to 375 mg of placebo every 2 or 4 weeks for 12 or 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 700- 2000 IU/mL) group received doses of 450 mg, 525 mg, or 600 mg of placebo every 2 weeks for 14 weeks. Patients in Xolair (Immunoglobulin E (IgE) = 301- 699 IU/mL) group received doses of 225 mg to 375 mg of placebo every 2 weeks for 6 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Early Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients
时间窗: Week 8, Week 16
The EAR was defined as the maximum percent drop in forced expiratory volume in one second (FEV1) in the first 30 minutes after the challenge: EAR = 100\* \[ FEV1 (0) - Minimum FEV1 (10, 15, 30 min)\] / FEV1 (0). For FEV1 (0), the "best post saline (Control) FEV1" was used. The EAR was analyzed using a linear (ANCOVA) model with a fixed effect for treatment groups and the EAR from the baseline challenge was used as a covariate.
次要结局
- Late Phase Allergic Response After Treatment With Study Drug in Active and Placebo Patients(Week 0, Week 8 and Week 16)