NL-OMON43415已完成3 期
A multi-centre, open label, single arm, 32-week treatment study in subjects with severe eosinophilic asthma not optimally controlled with current omalizumab treatment who are switched from omalizumab to mepolizumab 100mg subcutaneous (study number 204471- the OSMO study) - 204471 (OSMO)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* At least 12 years (NL: 18 years) of age.
- •* Asthma for *2 years that meets the National Heart and Lung Institute or GINA guidelines.
- •* Persistent airflow obstruction (*18 years: FEV1 <80% predicted, 12-17 years: <90% predicted) or FEV1/FVC ratio <0.8).
- •* Eosinophilic asthma, see protocol page 25 for details.
- •* Well-documented requirement for regular treatment with high-dose inhaled corticosteroid in the 12 months prior to Visit 1 with or without maintenance oral corticosteroids, see protocol page 25 for details.
- •* Additional controller medication, besides ICS: current treatment for at least 3 months or failure in the past 12 months for at least 3 successive months.
- •* ACQ-5 score *1.5.
- •* Omalizumab based on weight and IgE levels for at least the 4 months.
- •* History of two or more exacerbations in the past 12 months. For subjects receiving omalizumab for *8 months: at least one exacerbation must have occurred while on omalizumab treatment, see protocol page 26 for details.
- •* Adequate contraception for females of childbearing potential.
排除标准
- •* Presence of a known pre-existing, clinically important lung condition other than asthma.
- •* Diagnosis of chronic hepatitis B, as evidenced by positive Hepatitis B surface antigen.
- •* Clinically significant cardiovascular disease uncontrolled with standard treatment, see protocol page 28 for details.
- •* Other conditions that could lead to elevated eosinophils, see protocol page 28 for details.
- •* Known immunodeficiency, other than that explained by the use of corticosteroids for asthma.
- •* Current smokers or former smokers with a smoking history of *10 pack years see protocol page 29 for details.
- •* Pregnancy or breastfeeding
研究者
相似试验
进行中（未招募）
1 期
A open label, single arm, 32-week treatment study in subjects with severe eosinophilic asthma who are switched from omalizumab to mepolizumab 100mg subcutaneousSubjects with severe asthmaMedDRA version: 19.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2015-003697-32-BEGlaxoSmithKline Research & Development Ltd120
进行中（未招募）
1 期
A open label, single arm, 32-week treatment study in subjects with severe eosinophilic asthma who are switched from omalizumab to mepolizumab 100mg subcutaneousEUCTR2015-003697-32-SEGlaxoSmithKline Research & Development Ltd120
进行中（未招募）
1 期
A open label, single arm, 32-week treatment study in subjects with severe eosinophilic asthma who are switched from omalizumab to mepolizumab 100mg subcutaneousEUCTR2015-003697-32-ESGlaxoSmithKline, S.A.120
进行中（未招募）
1 期
A open label, single arm, 32-week treatment study in subjects with severe eosinophilic asthma who are switched from omalizumab to mepolizumab 100mg subcutaneousEUCTR2015-003697-32-DEGlaxoSmithKline Research & Development Ltd120
进行中（未招募）
1 期
A open label, single arm, 32-week treatment study in subjects with severe eosinophilic asthma who are switched from omalizumab to mepolizumab 100mg subcutaneousSubjects with severe asthmaMedDRA version: 19.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2015-003697-32-NLGlaxoSmithKline Research & Development Ltd120