The pharmacokinetics and anti-inflammatory effects of prednisolone in severe asthma. - Prednisolone in severe asthma

Imperial College0 个研究点目标入组 30 人开始时间: 2007年7月31日最近更新: 2019年2月28日

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•Severe asthma subjects:
•Physician diagnosis of asthma
•Aged 18 – 70
•Non-smokers or ex-smokers with less than 5 pack/year history
•Major characteristics (at least one of the following criteria)
•Treatment with continuous or near continuous (>50% of year) oral corticosteroids
•Requirement for treatment with high dose inhaled corticosteroids (ICS)
•Minor characteristics (at least 2 out of the following)
•1.Requirement for daily treatment with a controller medication in addition to ICS e.g. LABA, theophylline, leukotriene antagonist
•2.Asthma symptoms requiring SABA on a daily or near daily basis
•3.Persistent airways obstruction (FEV1 <80% predicted, diurnal PEF variation >20%)
•4.One or more emergency care visits for asthma per year
•5.3 or more steroid bursts” per year
•6.Prompt deterioration with = 25% reduction in oral or ICS
•7.Near fatal asthma event in the past
•Moderately-severe asthma:
•Physician diagnosis of asthma
•Aged 18 – 70
•Non-smokers or ex-smokers with less than 5 pack/year history
•Less than 2 courses of prednisolone per year
•Taking up to 2000 mcg of inhaled corticosteroid (BDP equivalent) per day
•Stable asthma for at least 6 months prior to enrolment
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Current smokers, or less than 3 years since quitting smoking
•Less than 4 weeks from an exacerbation
•Active peptic ulceration
•Previous history of psychiatric disturbances on high dose prednisolone
•On steroid-sparing agent or immunosuppressant such as azathioprine, methotrexate and ciclosporin
•Concomitant anti-IgE therapy

发起方

Imperial College