EUCTR2012-002198-72-GB进行中（未招募）1 期
Targeted retreatment of incompletely recovered COPD exacerbations with ciprofloxacin: a double-blind, randomised, placebo-controlled, multicentre Phase III trial - Targeted retreatment of COPD exacerbations
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 231
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
- •- Pre-existing diagnosis of COPD, which will be confirmed by post-bronchodilator FEV1/FVC ratio of <0.7 at screening
- •- Severity of disease: Patients with a measured FEV1<80% of predicted normal values
- •- COPD exacerbation 14 days prior to study enrolment, treated with 5-14 days of non-quinolone antibiotics
- •- Age: = 45 years of age at screening.
- •- Measured CRP (C-reactive protein) =8mg/L AND/OR persistence of one or more major symptom at the screening visit. The individual ‘major symptoms’ are dyspnoea, increased sputum purulence and increased sputum volume. Symptoms will be assessed and documented using a standardised short questionnaire completed by the patient.
- •- Able to complete questionnaires for health status and symptoms and to keep written diary cards
- •- Informed Consent: Patients must be able to give their signed and dated written informed consent to participate
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •Patients meeting any of the following criteria will not be enrolled in this study:
- •- Patients with other clinically predominant chronic respiratory disease. Patients with other respiratory diagnoses may be enrolled if COPD is the predominant condition (in the judgment of the study doctor) and if the additional diagnosis will not affect the safety of the patient or validity of their results.
- •- Intubated patients receiving invasive positive-pressure ventilation. Patients receiving non-invasive ventilation and/or oxygen therapy may be included if they otherwise fulfil the inclusion and exclusion criteria.
- •- Patients with known hypersensitivity to ciprofloxacin or any of the excipients used in its manufacture or that of the matched placebo.
- •- Patients on long term antibiotics for other conditions
- •- Patients already retreated with antibiotics for the current exacerbation (i.e. between day -14 and the screening visit)
- •- Patients who at the screening visit are too unwell for randomisation and/or fulfil one or more of the following criteria:
- •1) SaO2 <88% on air (OR less than their usual known baseline saturation level on their usual oxygen dose if using long-term oxygen therapy)
- •2) Systolic blood pressure <90mmHg OR >200mmHg
- •3) Resting tachypnoea >28 breaths/minute
- •4) Resting tachycardia >120 beats/minute
- •5) Drowsy or confused
- •6) Clinical examination suggesting pneumonia or complications (e.g. parapneumonic effusion/empyema)
- •7) Further antibiotic treatment required in the judgment of the study doctor and therefore would be at risk if randomised to the placebo arm
- •- Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding.
- •- Clinically relevant previously measured 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
- •- Patients who are actively enrolled in another interventional clinical trial (i.e. taking another IMP). Patients enrolled in observational COPD research (e.g. the London COPD Cohort Study [a recruitment source for this study] or COPDMAP) may continue as long as a) this study does not adversely impact on the scientific validity of the other study, and b) simultaneous participation is not unduly onerous for the patient. See section 8.8.
- •- Elderly patients (=80 years) on long-term (>6 weeks) systemic corticosteroids at a dose of =5mg/day prednisolone or equivalent [these patients have an increased risk of tendon rupture with ciprofloxacin].
- •- Patients with any other condition precluding enrolment in the trial, according to the assessment of the study doctor. This will be documented at screening.
研究者
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