The effect of a humanised monoclonal anti-IgE antibody (omalizumab) on disease control and bronchial mucosal inflammation in non-atopic ('intrinsic') asthma: a double-blind, randomised, placebo-controlled trial

King's College London (UK)0 个研究点目标入组 40 人开始时间: 2010年6月16日最近更新: 2017年10月9日

适应症

试验速览

暂无简介。

•1. Males and females aged 18 to 60 years inclusive
•2. Moderate/severe non-atopic asthma as defined below treated with inhaled corticosteroid for at least 6 months
•2.1. Daytime & night-time symptoms at least 3 days/week in the last 3 months prior to screening visit (despite taking inhaled corticosteroids with or without long-acting ß2- agonist or leukotriene blockers
•2.2. Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) 40-80% predicted; reversibility of =12% in FEV1 in response to inhaled ß?-agonist documented at any time within the past 2 years
•2.3. Negative skin prick and/or in vitro IgE tests to a range of 12 common aeroallergens
•2.3.1. pollens:
•2.3.1.1. grass
•2.3.1.2. hazel
•2.3.1.3. alder
•2.3.1.4. birch
•2.3.2. danders:
•2.3.2.1. cat
•2.3.2.2. dog
•2.3.3. dust mite:
•2.3.3.1. D.pteronyssinus
•2.3.3.2. D. farinae
•2.3.4. moulds
•2.3.4.1. Cladosporium
•2.3.4.2. Aspergillus
•2.3.4.3. Alternaria

•1. Smoking within the past year or total smoking history 0.5 pack years
•2. Pregnant or lactating females or those at risk of pregnancy
•3. Treatment with more than 2000 µg/day beclometasone, 1600 µg/day
•4. Budesonide or1000 µg/day fluticasone by inhalation or regular systemic corticosteroid at screening
•5. Hospitalisation for asthma or exacerbation requiring systemic corticosteroid therapy within 3 months of the screening visit
•6. History of life-threatening asthma, defined as an asthma episode that required intubations and/or was associated with hypercapnia, respiratory arrest and/or hypoxic seizures
•7. Patients in whom, in the opinion of the study investigators, omalizumab therapy might normally require precaution (a history of autoimmune disease, renal or hepatic impairment, hyper immunoglobulin E syndrome, Allergic bronchopulmonary aspergillosis and diabetes mellitus)

发起方

King's College London (UK)