The effect of a humanised monoclonal anti-IgE antibody (omalizumab) on disease control and bronchial mucosal inflammation in non-atopic (intrinsic”) asthma - Omalizumab

King's College London0 个研究点目标入组 40 人开始时间: 2009年5月15日最近更新: 2018年12月4日

适应症

试验速览

暂无简介。

•Males and females aged 18 to 75 years inclusive.
•Moderate/severe non-atopic asthma treated with inhaled
•corticosteroid, with or without oral corticosteroids(oral, up to 20mg/day prednisolone
•or equivalent) for at least 3 months prior to screening.
•Written, informed consent provided.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•Smoking within the last 3 months or total smoking history 10 pack years.
•Pregnant or lactating females or those at risk of pregnancy.
•Patients taking >20mg of prednisolone daily.
•Hospitalisation for asthma or exacerbation requiring systemic corticosteroid therapy
•within 3 months of the screening visit.
•History of life-threatening asthma, defined as an asthma episode that required
•intubation and/or was associated with hypercapnia, respiratory arrest and/or hypoxic
•seizures within the 6 months prior to screening.
•Pre bronchodilator FEV1 < 40% of the predicted.
•Patients in whom, in the opinion of the study investigators, omalizumab therapy
•might normally require precaution (current or suspected malignancy, current or
•suspected autoimmune disease, renal or hepatic impairment, hyperimmunoglobulin E
•syndrome, allergic bronchopulmonary aspergillosis , diabetes mellitus, current
•immunosuppressive therapy and known Churg-Strauss or hypereosinophilic

发起方