Safety and efficacy of parenteral keratinocyte growth factor (KGF) in moderate asthma subjects: a double-blind placebo-controlled randomised parallel group trial

Southampton University Hospitals NHS Trust (UK)0 个研究点目标入组 20 人开始时间: 2009年10月7日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Aged 18 - 50 years, either gender
•2. Confirmed diagnosis of asthma for greater than 1 year as defined by British Thoracic Society (BTS) guidelines, requiring treatment with high dose inhaled corticosteroids in combination with long acting beta-2-agonists, with persisting symptoms requiring use of short-acting beta agonist therapy greater than 3 x/week
•3. Lifelong non-smoker
•4. Forced expiratory volume in one second (FEV1) greater than 40%
•5. Subject must understand the procedures of the study and agree to participation in the study by providing written informed consent
•6. Subject considered fit enough to undergo lung function testing including provocation tests, and bronchoscopy
•7. Subject must not be participating in another clinical trial or have done so within the last 12 weeks

•1. Pregnancy (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin [hCG] laboratory test greater than 5 mIU/ml), an intention to become pregnant or breast-feeding (lactating)
•2. Subjects with active lung disease other than asthma
•3. Significant medical (cardiopulmonary, neurological, renal, endocrine, gastrointestinal, psychiatric, hepatic or haematological) co-morbidity which in the view of the investigator could impact on the interpretation of results or participation in the trial, or which is uncontrolled with standard treatment
•4. Current participation in another clinical trial or previous participation within the last 12 weeks
•5. Alcohol or active drug abuse
•6. Ongoing allergen desensitisation therapy
•7. Regular use of sedatives, hypnotics, tranquilisers
•8. Cancer or previous history of cancer
•9. Inability to understand directions for dosing and study assessment
•10. Inability to be contacted in case of emergency

发起方

Southampton University Hospitals NHS Trust (UK)