A Phase III Single-blind, Randomised Placebo Controlled Trial of Long Term Therapy in Patients With Stable COPD Using Moxifloxacin, Azithromycin and Doxycycline: a Bayesian Decision Analysis, Including Other Criteria, Will be Used to Distinguish the Optimal Antibiotic Treatment
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is the cause of considerable deaths, and exacerbations (flare up of symptoms) are a major cause of hospital admission in the UK. Bacterial infections play an important role in the development of COPD, however, there is little information available about the use of long term antibiotics in the treatment of this disease. Therefore the purpose of this study is to identify the best antibiotic regime for treating patients with COPD who have persistent bacterial infection in their lung. We will test a variety of approaches including both older and newer regimes prescribed either on a daily basis at a lower dose or in "pulsed" courses (for example, every other day or five days every month). The three antibiotics tested in this study are: moxifloxacin, azithromycin and doxycycline. This is a 13 weeks study conducted at the Royal Free Hospital, London. It is expected that approximately 200 patients will be selected for this study. The information we get from this study may help us to treat future patients with COPD better.
详细描述
This is a 14 week study in which 200 patients with COPD will be selected for this study from GP practices up to a 15 mile radius from the Royal Free Hospital to participate in this study. The 3 antibiotic regimes (plus a placebo group) will be used in this study are:
Moxifloxacin: an oral dose of 400 mg once daily for 5 consecutive days every 4 weeks.
Azithromycin: an oral dose of 250 mg once daily three times a week (every other day).
Doxycycline: an oral dose of 100 mg once daily.
Placebo will be given as one table once daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed COPD diagnosis
- •Informed Consent: Patients must give their signed and dated written informed consent to participate
- •Gender: Male or female patients
- •Age: ≥ 45 years of age at screening
- •Produce sputum regularly (produce sputum in at least 3 months of a year)
- •Able to complete questionnaires for health status and symptoms and considered able to comply with the dosing regimen.
- •Severity of disease: Patients with a measured FEV1<80% of predicted normal values as determined at screening. An average of three spirometry readings will be taken.
排除标准
- •Patients with TB, other chronic respiratory disease (e.g. chronic asthma, bronchiectasis, pulmonary fibrosis), patients with hepatic or renal impairment and patients with prolonged QT interval and other cardiac abnormalities.
- •Patients with known hypersensitivity to the antibiotics under evaluation.
- •Patients on long term antibiotics for other conditions.
- •Patients with uncontrolled hypertension.
- •Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding.
- •Patients with a history of long QT syndrome or whose QTc measured at Visit 1 is prolonged (>450 msec for males and females) as confirmed by the ECG assessor.
- •Clinically relevant abnormal laboratory values at the screening assessment that could interfere with the objectives of the trial or safety of the volunteer.
- •Patient taking clinically significant contraindicated medication, as per the SmPCs
研究组 & 干预措施
Moxifloxacin
干预措施: Moxifloxacin (Drug)
Azithromycin
干预措施: Azithromycin (Drug)
Doxycycline
干预措施: Doxycycline (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To measure and compare reduction in the concentration of lower airway bacteria in patients with COPD between three different antibiotic regimes and placebo
时间窗: Week 14 post treatment
次要结局
- To measure changes in lung function measure, health status and exacerbations.(week 14 post treatment)