EUCTR2008-000609-12-BE进行中（未招募）不适用
Open, randomized, two-way crossover, pilot study to assess the effect of Salbutamol in comparison with Ipratropium bromide on central and peripheral airway dimensions in COPD patients
niversity Hospital Antwerp; Department Respiratory Medicine0 个研究点开始时间: 2008年5月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •1.Patients with documented COPD based on the following criteria:
- •Smoking history of at least 10 pack-years.
- •Decreased Tiffeneau index (FEV1/(F)VC < 0.70).
- •2.Patients aged = 40 years.
- •3.Patients should present moderate to severe COPD with an FEV1 between 30 and 80% of predicted (GOLD 2 and 3).
- •4.Patients should be treated according to GOLD guidelines.
- •5.Able to inhale study drug.
- •6.Maintained on stable respiratory medications for 6 weeks prior to visit 1.
- •7.Able to perform lung function tests.
- •8.Able to follow study procedures.
- •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
- •1.Patients who are allergic to salbutamol, ipratropium bromide or to another element of the product.
- •2.Patients allergic to sojalecithin and products on the basis of soja and peanut.
- •3.Patients who have or ever had glaucoma.
- •4.Patients with urinary problems, prostate hyperplasy or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included.
- •5.Patients with a recent history (i.e. six months or less) of myocardial infarction.
- •6.Patients with any unstable or life threatening cardiac arrhythmia.
- •7.Patients with severe kidney insufficiency (creatinine clearance =50 ml/min)a.
- •8.Patients below the age of 40.
- •9.Patients who are pregnant or are breast-feeding.
- •10.Patients who are treated with other anticholinergic medications, that cannot be stopped during the study period.
- •11.A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
- •12.Significant alcohol or drug abuse within the past 12 months.
- •13.Participation in another trial with an investigational drug within one month or six half lives (whichever is greater) prior to screening visit.
- •14.Known active tuberculosis.
- •15.A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
- •16.A history of thoracotomy with pulmonary resection.
- •17.Active or untreated malignancy.
- •18.Use of oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at doses = 10 mg/day.
- •a Cockroft’s formulae should be applied:
- •in male: creatinine clearance = (140-age) x weight / 72 x creatininemia
- •in female: creatinine clearance = 0.85 x (140-age) x weight / 72 x creatininemia
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