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临床试验/EUCTR2007-006576-11-GB
EUCTR2007-006576-11-GB进行中(未招募)1 期

Macrolides in Refractory Asthma

ottingham University0 个研究点目标入组 0 人开始时间: 2008年5月2日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • Non-smoking subjects aged 16 to 80 with refractory asthma, FEV1 >50% predicted and >1L and measurable airway responsiveness to methacholine challenge. Refractory asthma will be defined as an FEV1/FVC ratio less than 70% with evidence of poor asthma control in terms of regular night-time awakening (>2/week) or more than 4 puffs of relief medication/day (>twice/week) requiring repeated (2 or more per year) courses of oral corticosteroids despite treatment with high dose inhaled corticosteroids (=1000mg beclomethasone or equivalent) and treatment with, or a previous unsuccessful trial of, a long-acting beta-agonist or leukotriene antagonist.
  • 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

排除标准

  • Poor compliance with their usual asthma treatment as assessed by a review of primary care records, pregnancy, inadequate contraception or lactation, active smoking or smoking history in excess of 20 pack years, a clinical diagnosis of ABPA or significant bronchiectasis, other major co-morbidity including abnormal liver function tests or medication known to interact with azithromycin (aprepitant, atazanavir, atorvastatin, carbamazepine, ciclosporin, colchicine, disopyramide, efavirenz, eletriptan, eplerenone, itraconazone, ivabradine, methylprednisolone, midazolam, omeprazole, phenytoin, pimozide, repaglinide, ritabutin, rifamycins, ritonavir, sildenafil, simvastatin, sirolimus, tacrolimus, tadalafil, theophylline, tipranavir, tolterodine, verapamil, warfarin and zidovudine)

研究者

发起方
ottingham University

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