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临床试验/EUCTR2010-021412-42-GB
EUCTR2010-021412-42-GB进行中(未招募)1 期

Prospective randomised controlled trial to investigate the effectiveness of inhalers for the relief of breathlessness in patients with lung cancer and COPD - Airway disease optimisation of pharmaco-therapy in lung cancer

Royal Marsden Hospital0 个研究点目标入组 65 人开始时间: 2010年10月8日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
65

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.Male or female, age > 35 years
  • 2.Diagnosis of lung cancer ( Non-small cell lung cancer, Small cell lung cancer and mesothelioma)
  • 3.Diagnosis of chronic obstructive pulmonary disease (COPD)
  • 4.Subjective dyspnoea (breathlessness) of VAS score >/= 4
  • Are the trial subjects under 18?
  • 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)
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.Involvement in any other studies of breathlessness
  • 2.Reversible causes of breathlessness
  • 3.Patients receiving radiotherapy, chemotherapy, biological therapy or surgery. Or with a plan to commence these treatments within 4 weeks
  • 4.Current use of bronchodilators either inhaled or oral (aminophyline, methyxanthines) except for short-acting bronchodilators
  • 5.Recent change to oral corticosteroid therapy dose (within 1 week of randomisation)
  • 6.Current use of beta-blockers for any reason
  • 7.Current use of anti-cholinergic containing drugs
  • 8.Current use of potent CYP30 inhibitors (ritonavir, ketoconazole, itraconazole)
  • 9.Patients with the following conditions: asthma, severe cardiovascular disorders (myocardial infarction within 6 week), heart rhythm abnormalities, thyrotoxicosis, uncorrected hypokalaemia, glaucoma, prostate problems, patients with difficulty passing urine, renal failure, TB (current or previous)
  • 10.Pregnancy
  • 11.Patients with hypersensitivity to any of the study drugs, lactose allergy

研究者

发起方
Royal Marsden Hospital

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