NCT00132860Unknown4 期
Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease: A Prospective, Randomized, Double-Blind Placebo-Controlled Study of Intermittent, Prophylactic Antibiotic Treatment With Azithromycin
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- change in postbronchodilator FEV1
研究概览
简要总结
The purpose of the study is to investigate, in patients with moderate to severe chronic obstructive lung disease, whether intermittent antibiotic treatment leads to:
- A slower rate of decline in forced expiratory volume in one second (FEV1);
- A reduction in the frequency and severity of exacerbations;
- Fewer hospital admissions for chronic obstructive pulmonary disease (COPD);
- Lower mortality;
- An improved quality of life as compared to a group of placebo treated patients.
详细描述
Study Population: Patients with moderate to severe chronic obstructive lung disease.
Trial Phase: IV
Study Design: Prospective, randomised, double-blind, placebo- controlled clinical trial.
Study Medicine: Azithromycin.
Drug Administration: Oral.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
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 above 50 years of age, with a current admission for exacerbation of COLD or at least one admission within the previous two years.
- •Current or ex-smoker
- •Postbronchodilator FEV1 < 60% in stable condition (> 4 weeks after hospitalisation)
- •< 300 ml bronchodilator reversibility in FEV1
排除标准
- •Patients with end-stage COLD, who are not expected to survive for 3 years (typically bedridden patients being dyspnoeic in rest).
- •Patients with known other respiratory tract infection, e.g. tuberculosis or aspergillosis, in whom the intervention is known to be inefficient.
- •Patients with pulmonary malignancy
- •Patients with other pulmonary diseases than COLD.
- •Patients with immunodeficiency. However, COLD patients treated with steroids can be included.
- •Patients with known hereditary disposition to lung infections such as alfa-1-antitrypsin deficiency, cystic fibrosis or primary ciliary dyskinesia.
- •Patients receiving longterm antibiotic treatment ( e.g. recurrent cystitis).
- •Patients with known allergy or intolerance to azithromycin
- •Pregnant or breastfeeding women
- •Manifest heart, liver or renal insufficiency
- •Patients that, for reasons not stated above, are unlikely to be able to participate in a study period of 3 years.
结局指标
主要结局
change in postbronchodilator FEV1
次要结局
- number of hospital admissions and number of hospital days
- mortality
- quality of life
- use of medication
- prevalence of respiratory pathogens
- prevalence of macrolide resistance
- inflammatory parameters
研究者
研究点 (2)
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