MACrolides in Refractory Asthma: a single-centre randomised placebo-controlled two-period cross-over trial

niversity of Nottingham (UK)0 个研究点目标入组 20 人开始时间: 2009年1月23日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Non-smoking subjects
•2. Aged 16 to 80 years, either sex
•3. Refractory asthma, forced expiratory volume in one second (FEV1) greater than 50% predicted and greater than 1L and measurable airway responsiveness to methacholine challenge
•Refractory asthma will be defined as an FEV1/forced vital capacity (FVC) ratio less than 70% with evidence of poor asthma control in terms of regular night-time awakening (greater than 2/week) or more than four puffs of relief medication/day (greater than twice/week) requiring repeated (two or more per year) courses of oral corticosteroids despite treatment with high dose inhaled corticosteroids (at least 1000 µg beclomethasone or equivalent) and treatment with, or a previous unsuccessful trial of, a long-acting beta-agonist or leukotriene antagonist.

•1. Poor compliance with usual asthma treatment
•2. Pregnancy
•3. Inadequate contraception or lactation
•4. Active smoking or smoking history in excess of 20 pack years
•5. A clinical diagnosis of allergic bronchopulmonary aspergillosis or significant bronchiectasis
•6. Other major co-morbidity including abnormal liver function tests or medication known to interact with azithromycin

发起方

niversity of Nottingham (UK)