JAB02 Repurposing allopurinol as a novel anti-inflammatory treatment for persistent allergic asthma. - JAB02 Allopurinol as a novel anti-inflammatory treatment for Asthma

Tayside Medical Sciences Centre on behalf of University of Dundee0 个研究点目标入组 18 人开始时间: 2019年7月9日最近更新: 2019年12月16日

适应症

试验速览

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•Male and female volunteers aged 18-65 years with stable mild to moderate asthma. Steroid naïve or receiving inhaled steroid up to 1000µg/day BDP equivalent dose, who are responsive to bronchial mannitol challenge – i.e. with a provocative mannitol dose to produce a 15 % fall in FEV1 (PD15) =635mg for bronchial challenge. Patients must be able to step down and stop inhaled corticosteroids (ICS), long acting ß-2 agonists (LABAs), leukotriene receptor antagonists (LTRAs), cromones, antihistamines, and remain be clinically stable throughout the study. This is defined as: FEV1 =60% predicted; Peak flow (PEF) =70% of reference value at screening; reliever use not >8puffs/day on two consecutive days
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 16
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•Other significant pulmonary disease (e.g. COPD) Smoking within 12 months of screening visit, uncontrolled symptoms of asthma; Pregnancy or lactation; known or suspected sensitivity to IMP; Inability to comply with protocol; Any clinically significant medical condition that may endanger the health or safety of the participant, or jeopardise the protocol; An asthma exacerbation requiring systemic steroids within 3 months of study commencement; Taking prohibited medication (as defined in protocol), Participation in another CTIMP within the past 30 days.

发起方

Tayside Medical Sciences Centre on behalf of University of Dundee