EUCTR2005-000841-12-DE进行中（未招募）不适用
A randomised open label, six way, cross-over scintigraphic evaluation of the effect of inspiratory flow rate on lung and oropharyngeal deposition with the Respimat(R) inhaler vs a Metered Dose Inhaler (HFA-MDI) using Berodural(R) in patients with Chronic Obstructive Pulmonary Disease (COPD)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
- 性别
- All
入选标准
- •Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 <=65% of predicted normal and FEV1 <=70% of FVC.
- •Current or ex-smokers with a smoking history of >=10 pack years.
- •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
- •Patients who have frequent exacerbations which could be expected to interfere with the patients ability to participate in the trial should be excluded. The enrolment of patients who have had an exacerbation within the six weeks prior to planned study entry should be postponed.
- •Patients with a recent history (i.e. six months or less) of myocardial infarction.
- •Patients with any unstable or life-treatening cardiac arrhythmia or who have been hospitalised for heart failure within the past years.
- •Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy.
- •Patiens with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
- •Patients with any upper respiratory infection in the past 14 days prior to the Screnning Visit (Visit 1) or during the baseline period or lower respiratory tract infection within the last 3 months.
- •Patients who are being treated with cromolyn sodium or nedocromil sodium.
- •Patients who are being treated with antihistamines (H1 receptor antagonists).
- •Patients using oral corticosteroid medication at unstable doses (i.e. less thant six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day.
- •Patients who have taken an investigational drug within 30 days or six half lives (whichever is the greater) prior to Screening Visit (Visit 1) and/or the administration of radio-labelled dosage forms (within a clinical trial) within the calendar year.
研究者
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