The Effect of a Humanised Monoclonal Anti-IgE Antibody,Omalizumab, on Disease Control and Bronchial Mucosal Inflammation in Non-atpic Asthma
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pre-bronchodilator FEV1
研究概览
简要总结
Hypothesis- Omalizumab(humanized monoclonal anti-IgE antibody)improves disease control and reduces bronchial mucosal inflammation in non-atopic asthma.
In order to test the above hypothesis, the investigators propose a placebo controlled, double blind, parallel group study to obtain proof of principle that omalizumab exerts beneficial effects on disease control in non-atopic severe adult asthmatics aged 18-60 years . Forty patients will be randomized in a 1:1 ratio to receive omalizumab or matching placebo. Following 12 weeks of treatment with omalizumab/placebo, and as this treatment is continued for a further 8 weeks, anti-asthma treatment will be reduced. Dosages will be administered at 4 or 2 weekly intervals over a 16 week period (5 or 10 doses in total), which corresponds with the time stated as necessary to judge efficacy of therapy according to omalizumab's licensed indications in atopic asthma. Efficacy will be judged by clinical monitoring and by bronchial biopsy to assess effects on bronchial inflammation and local IgE production.
详细描述
The primary aim of the study is to obtain proof of principle that omalizumab therapy maintains lung function, symptom control and quality of life in a group of non-atopic, moderate/severe asthmatics whose regular anti-asthma therapy is uniformised and reduced for an 8 week period following omalizumab/placebo therapy while the latter therapy is continued.
A secondary aim is to see whether omalizumab, as compared with placebo therapy reduces bronchial inflammation and local IgE production in the bronchial mucosa of this same group of asthmatics.
Clinical outcome measures
The omalizumab and placebo treated groups will be compared for changes in the following clinical outcomes (for repeated measurements such as daily peak flow and symptoms the mean values of the first and last 10 days of the relevant study period will be compared).
- prior to reduction of existing anti-asthma therapy (first 12 weeks of study):
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Omalizumab
There are 2 arms of the study; patients in one arm receiving omalizumab and in the other arm receiving placebo.
干预措施: Omalizumab (Drug)
Placebo
There are 2 arms of the study; patients in one arm receiving omalizumab and in the other arm receiving placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Pre-bronchodilator FEV1
时间窗: before and after treatment with omalizumab for 16 weeks
Prior to reduction of existing anti-asthma therapy (first 12 weeks of study): • Pre-bronchodilator FEV1 (primary outcome measure)
Disease exacerbation
时间窗: From week 12 to week 20 of the study
During anti-asthma therapy reduction phase (subsequent 8 weeks of study): The primary outcome measure during asthma therapy reduction phase will be disease exacerbation defined as a need for rescue oral corticosteroid medication for worsening of symptoms and/or deterioration in lung function, as agreed between the patient and the study physician
次要结局
- Day and night time symptom scores(before and after treatment with omalizumab for 16 weeks)
- Morning and evening peakflows(before and after treatment with omalizumab for 16 weeks)
- Exhaled nitric oxide(before and after treatment with omalizumab for 16 weeks(from week 0 to week 16))
- Total dosage of rescue beta-2-agonists(before and after treatment with omalizumab for 16 weeks(from week 0 to week 16))
- Total symptom free days(before and after treatment with omalizumab for 16 weeks(from week 0 to week 16))
- Quality of life scores(before and after treatment with omalizumab for 16 weeks(from week 0 to week 16))
- Markers of airway remodelling and inflammation(before and after treatment with omalizumab for 16 weeks(from week 0 to week 16))
- Local IgE synthesis in the bronchial mucosa and its expression(before and after treatment with omalizumab for 16 weeks(from week 0 to week 16))