An Exploratory, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of Multiple Doses of Omalizumab in Cystic Fibrosis Complicated by Allergic Bronchopulmonary Aspergillosis (ABPA)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change From Baseline, as Measured by the Percentage of Participants Requiring Rescue With Corticosteroids, and as Measured by the Time to Deviation From the Protocol Prescribed Steroid Tapering Regimen
研究概览
简要总结
This study will evaluate the safety and efficacy of omalizumab for the treatment of Allergic Bronchopulmonary Aspergillosis (ABPA) in patients with Cystic Fibrosis aged 12 years and older.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Cystic Fibrosis complicated by Allergic Bronchopulmonary Aspergillosis (ABPA)
- •Oral corticosteroid use for ABPA flare
- •Age 12 years and older (except for Italy; ≥ 18 years)
- •Total serum IgE levels ≥ 500 IU/mL
排除标准
- •History of cancer in the last 10 years.
- •History of severe allergic reactions
- •Pregnant and lactating women
- •Prior use of Xolair
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Omalizumab
Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
Participants who completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.
干预措施: Omalizumab (Drug)
Omalizumab
Eligible participants received a maximum dose of 600 mg omalizumab via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. A maximum 600 mg dose required 4 injections. All participants who entered the study received itraconazole twice daily, while receiving oral corticosteroids, with a maximum daily dose of 400 mg.
Participants who completed double-blinded phase, entered open-label treatment period of 6 months and continued the same regimen of omalizumab of double-blinded phase.
干预措施: Itraconazole (Drug)
Placebo
Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
干预措施: Placebo (Drug)
Placebo
Eligible participants received placebo comparator via subcutaneous injection for 6 months in the double-blind phase of the study. The study medication was to be administered at the same time of day. Study medication was injected subcutaneously into the upper arm in the area of the deltoid or to the thigh. All participants who entered the study received itraconazole twice daily, while on oral corticosteroids, with a maximum daily dose of 400 mg.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Change From Baseline, as Measured by the Percentage of Participants Requiring Rescue With Corticosteroids, and as Measured by the Time to Deviation From the Protocol Prescribed Steroid Tapering Regimen
时间窗: 6 months of blinded treatment
次要结局
- Change in Allergic Bronchopulmonary Aspergillosis (ABPA) Exacerbation Rates During Double-blind Treatment Period and Open-label Treatment Period(6 months, 12 months)
- Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline, Measured at 3 and 6 Months of Treatment(3 months, 6 months)
- Time to Steroid Free State.(12 months)
- Change From Baseline in Average Oral Corticosteroid Use.(6 months, 12 months)
- Percentage of Participants Responding to Omalizumab, as Defined by a Reduction in Oral Corticosteroid Dose Use of 50% or More as Compared to Baseline(6 months, 12 months)