A 24-week, Phase III Randomized, Double-blind, Placebocontrolled, Parallel-group, Multicenter Study of Xolair® (Omalizumab) in Patients With Moderate to Severe Persistent Allergic Asthma Who Remain Not Adequately Controlled Despite GINA (2009) Step 4 Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 616
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period
研究概览
简要总结
This study will assess the efficacy, safety and tolerability of omalizumab, compared to placebo in 18 to 75 year old Chinese patients with moderate to severe persistent allergic asthma who have inadequate asthma control despite treatment according to GINA (2009) Step 4 therapy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Met study drug-dosing table eligibility criteria (serum baseline total IgE level ≥ 30 to ≤ 700 IU/mL and body weight > 20 kg and ≤ 150 kg)
- •Diagnosed with asthma ≥ 1 year duration at Screening, and a history of asthma that is not adequately controlled with GINA (2009) Step 4 therapy
- •Received medium-to-high dose inhaled corticosteroid > 500 µg Beclomethasone Diproprionate (BDP), or equivalent plus regularly inhaled LABA, either separately or in combination, for at least 8 weeks prior to screening
- •Met specific asthma exacerbations eligibility criteria prior to the screening period
- •Exhibited inadequate symptom control as demonstrated by specific criteria (in keeping with GINA 2009 guidelines)
- •Positive skin prick test to at least one perennial aeroallergen documented by a historical test within 12 months prior to screening, or at Visit 1
- •FEV1 ≥ 40% and < 80% of the predicted normal value for the patient (using local standards), after withholding bronchodilators at Visit 2
排除标准
- •Used other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. For biological agent-based investigational drugs, such as monoclonal antibodies, at least six months will need to have passed between the last administration of the drug and the patient's Screening Visit.
- •History of malignancy
- •History of allergies and diseases that could interfere with the analyses
- •Clinically significant abnormality on a 12-lead ECG recorded at Visit 1
- •Elevated IgE levels for reasons other than allergy
- •Current smokers, or a former smoker with a smoking history of > 10 pack-years. A former smoker must have abstained for a minimum of 12 months before randomization
- •Receiving specific medications
- •Clinically significant laboratory abnormalities (not associated with the study indication) at Visit 1
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Omalizumab
Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
干预措施: Omalizumab (Drug)
Placebo
The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Morning Peak Expiratory Flow (PEF) Following the 24-week Treatment Period
时间窗: Baseline, 24 weeks
A Peak Expiratory Flow (PEF) meter was distributed to patients at Visit 1, to be used to measure PEF twice-daily as directed. During the Screening and Treatment Periods, PEF was measured in the morning and evening every day. the morning PEF was performed within 15 minutes after waking, and the evening PEF approximately 12 hours later. Patients were encouraged to perform morning and evening PEF measurements before the use of any LABA or rescue medication. The highest of 3 values was recorded as the daily personal best. The personal best was used to calculate the mean morning PEF and mean evening PEF value collected between assessment Visits LS Mean of change from baseline in mean morning PEF is calculated with the ANCOVA model using treatment, stratification group, dosing schedule, gender, center grouping, smoking status, and baseline mean morning PEF as covariates.
次要结局
- Change From Baseline in % Predicted FEV1 Following 24-week Treatment(Baseline, 24 weeks)
- Change From Baseline in Number of Puffs of Asthma Rescue Medication Following 24-week Treatment(24 weeks)
- Percentage of Patients Achieving at Least a 0.5, 1.0 or 1.5 Point Improvement From Baseline in AQLQ Overall Score Following 24-week Treatment(24 weeks)
- Change From Baseline in AQLQ Score Following 24-week Treatment(24 weeks)
- Change From Baseline in ACQ Score Following 24-week Treatment(24 weeks)
- Percentage of Patients With at Least a 0.5 or 0.75 Point Improvement in the ACQ Score at Week 24(24 weeks)
- Change From Baseline in Asthma Symptom Scores Following 24-week Treatment(24 weeks)
- Change From Baseline in Mean Evening PEF (L/Min) Following 24-week Treatment(Baseline, 24 weeks)
- Percentage of Participants With Investigator and Patient Global Evaluation of Treatment Effectiveness (GETE) at Weeks 16 and 24(16 and 24 weeks)