Does 1-alpha,25-dihydroxyvitamin D3 (calcitriol) enhance corticosteroid activity in steroid refractory asthma?A randomised control trial to test whether active vitamin D can improve the clinical response to steroids in asthmatic patients. - Vitamin D and steroid resistant asthma

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10日

适应症

试验速览

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•1.Male or Female adults aged between 18 to 75 years.
•2.Documented history and typical symptoms of asthma for = 6 months prior to screening.
•3.Pre-bronchodilator FEV1 < 80% predicted and documented variability in airways obstruction of 12% or greater within the previous 5 years or diurnal Peak Flow variability of > 20%.
•4.Corticosteroid refractory asthma, as defined by a < 10% improvement in FEV1 following a 14 day course of prednisolone 40mg/1.73m2/day29-31.
•5.Written informed consent received.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•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

•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 >2.66mmol/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.Current or previous allergen immunotherapy.
•9. Concomitant treatment with lithium carbonate or calcium supplements. Thiazide diuretics are a contraindication if the participant is taking calcium supplements at the same time.
•10.Inability to understand or comply with the research protocol

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