EUCTR2008-007240-34-GB进行中（未招募）1 期
Effect of macrolides on asthma control, airway inflammation and bacterial colonisation in smokers with asthma - Macrolide Asthma Study
HS Greater Glasgow & Clyde Hospitals & University of Glasgow0 个研究点目标入组 80 人开始时间: 2009年4月16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
- 入组人数
- 80
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
- •Inclusion criteria
- •1. Diagnosis of asthma: Typical symptoms [episodic wheezing, chest tightness and/or dyspnoea] And either reversible airflow obstruction (> 12% and 200 ml change in FEV1 with nebulised salbutamol 2.5 mg) at any study visit prior to randomisation
- •or methacholine airway hyperresponsiveness [20% drop in FEV1 at a concentration of methacholine = 8 mg/ml].
- •2. Age range 18-70 years [subjects above the age of 60 should have had asthma symptoms starting before the age of 40]
- •3. Duration of asthma symptoms > 1 year and on stable medication for 4 weeks
- •4. Able to maintain asthma without exacerbations at BTS step 2 level (beclometasone dose of 400 mcg/day and salbutamol as required) during the run-in period of the study.
- •5. Able to wean off other asthma medication, other than inhaled corticosteroid and short acting bronchodilator in the two weeks prior to the screening visit.
- •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
- •Exclusion criteria
- •1. Ex-smokers or never smokers
- •2. Planning to quit smoking during duration of trial
- •3. Patients with unstable asthma; defined as the presence of 1 or more of the following events in the month prior to randomisation [Emergency/’out of hours’ visit of patients to the GP; GP visit to patient at home; A & E hospital attendance; hospital admission].
- •4. Patients with current epilepsy, psychosis or history of significant atrial or ventricular tachyarrhythmia.
- •5. Corrected QT-interval greater than 450 msec in women and greater than 430 msec in men on baseline electrocardiogram (ECG).
- •6. Low potassium levels [less than normal values for the laboratory]. If low potassium can be corrected, screening can continue with confirmation of normal levels prior to taking study medication.
- •7. Liver disease (alanine transaminase and/or aspartate transaminase levels 2 or more times the upper limit of normal).
- •8. Significant renal disease: creatinine or urea levels 2 or more times the upper limit of normal.
- •9. Any previous severe adverse reaction to macrolides.
- •10. Patients who are known to have specific IgE sensitivity or skin test positivity to grass pollen allergen and a history of worsening of asthma due to hay fever, will not be recruited from mid May to the end of July (grass allergen season in UK).
- •11. Upper or lower respiratory tract infection in the 4 weeks prior to randomisation. Run-in period can be prolonged in this situation to have 4 weeks with no respiratory infection prior to randomisation.
- •12. Patients who require medications known to interact with azithromycin including:
- •- anti-psychotics, including Reboxitine and Quetiapine
- •- antivirals, including Nelfinavir, Zidovudine, Didanosine
- •- bromocriptine
- •- carbergoline
- •- clozapine
- •- coumarin-Type Oral Anticoagulants including warfarin
- •- cyclosporin
- •- ergot derivatives
- •- itraconazole
- •- midazolam
- •- mizolastine
- •- moxifloxacin
- •- rifamycins
- •- theophylline
- •- vinblastine
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