NCT04658277Unknown不适用
Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- number of infectious exacerbations
研究概览
简要总结
clarithromycin may reduce the exacerbations in middle-aged and elderly patients with non-CF bronchiectasis.
The study is aimed to (A) investigate the etiologies and clinical features of patients with bronchiectasis, (B) compare the effect of clarithromycin 250mg daily on the frequency of exacerbations, quality of life and lung function, stratified according to the degree of bronchiectasis severity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 50 years or older
- •At least 2 or more exacerbation requiring antibiotic treatment in the past year Clinically stable for at least 4 weeks prior to enrollment (defined as no symptoms of exacerbation, no requirement for supplemental antibiotic therapy)
- •Diagnosis of bronchiectasis defined by high-resolution computed tomography (CT) scan
排除标准
- •History of cystic fibrosis; hypogammaglobulinemia; allergic bronchopulmonary aspergilosis,
- •Cigarette smoking within 6 months
- •A positive culture of non-tuberculosis mycobacteria in the past 2 years or at screening
- •Macrolide treatment for more than 3 months in the past 6 months
- •Oral or intravenous courses of corticosteroids within 30 days of screening
- •Any antimicrobial treatment for lower respiratory tract infection in the last 2 weeks
- •Unstable arrhythmia
- •History of coronary artery disease, or symptoms of heart disease
- •Known allergy or intolerance to macrolides
- •Patients with liver disease or with elevated transaminanse (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels equal to or greater than the upper limit of the normal)
- •Concurrent medication: Colchicine, calcium channel blocker, statins, amiodarone, amitriptyline, trazodone, citalopram, disopyramide, itraconazole, saquinavir, ritaonavir, atazanavir, sildenafil, tadalafil, vardenafil, theophylline, carbamazepine.
研究组 & 干预措施
Treatment
Active Comparator
Patients will be given one tab of Clarithromycin 250mg daily.
干预措施: Clarithromycin (Drug)
usual care
Placebo Comparator
Patients will receive usual medical care
干预措施: Usual care (Other)
结局指标
主要结局
number of infectious exacerbations
时间窗: 26 weeks
次要结局
- change of St George Respiratory Questionnaire Score(26 weeks)
- Time to first exacerbation (Days)(26 weeks)
- Rate of symptom-based exacerbations (number of events per month)(26 weeks)
- change of post bronchodilator Forced Expiratory volume in 1 sec and forced vital capacity(26 weeks)
- change of exercise capacity (flights of stairs)(26 weeks)
- change of concentration of serum c-reactive protein (mg/L)(26 weeks)
研究者
Susanna SS Ng
Assistant Professor
Chinese University of Hong Kong
研究点 (1)
Loading locations...
相似试验
Unknown
3 期
Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma HominisBronchopulmonary DysplasiaNCT01652118Zekai Tahir Burak Women's Health Research and Education Hospital250
已完成
不适用
Does administration of clarithromycin prevent pneumonia due to ventilator use?ventilator-associated pneumonia.Pneumonia, unspecifiedIRCT2014121620341N1Shahid Sadoughi University of Medical Sciences60
已完成
不适用
Effect of long-term clarithromycin antibiotic therapy on preventation of pneumonia in the elderly: a prospective randomised controlled trial.pneumoniaJPRN-UMIN000023355Department of Respiratory Medicine and Infectious Diseases, Oita University Faculty of Medicine200
暂停
不适用
A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic FibrosisCystic FibrosisNCT00005110National Center for Research Resources (NCRR)
已完成
3 期
Use of COLD-fX to Prevent Respiratory Infections in Community Dwelling SeniorsRespiratory Tract InfectionNCT00240461Capital Health, Canada780