Does 1-alpha, 25-dihydroxyvitamin D3 (calcitriol) enhance corticosteroid activity in steroid refractory asthma? A randomised controlled trial

King?s College London (UK)0 个研究点目标入组 80 人开始时间: 2009年5月7日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Male or female adults aged between 18 to 65 years
•2. Documented history and typical symptoms of asthma for greater than or equal to 6 months prior to screening
•3. Pre-bronchodilator forced expriatory volume in one second (FEV1) less than 70% predicted and greater than 15% reversibility to beta 2-agonist or diurnal peak flow variability of greater than 20%
•4. Corticosteroid refractory asthma, as defined by a less than 15% improvement in FEV1 following a 14-day course of prednisolone 40 mg/1.73 m^2/days 29 - 31
•5. Written informed consent received

•1. Past or present disease, which, as judged by the investigator, may affect the study outcome (other than asthma, rhinitis or eczema)
•2. Serum corrected calcium greater than 2.66 mmol/l
•3. Clinically significant deviation from normal (physical examination or laboratory parameters) as judged by the investigator at the screening visit
•4. Current smoker or an ex-smoker of less than 5 years with a greater than 5 pack year history
•5. Pregnant or lactating females or those at risk of pregnancy (women of childbearing age may be offered a pregnancy test prior to recruitment)
•6. History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks of the screening visit requiring oral corticosteroid tablets
•7. Participation in a study involving an investigational medicinal product in the previous 3 months or blood donation within the last year
•8. Participants taking regular medications for diseases other than those for asthma or rhinitis
•9. Current or previous allergen immunotherapy
•10. Concomitant treatment with a thiazide diuretic or calcium supplement
•11. Inability to understand or comply with the research protocol

发起方

King?s College London (UK)