EUCTR2007-001051-19-DE进行中（未招募）不适用
A double-blind, randomized, cross-over, placebo-controlled, 2-part study to compare the effect of exercise and high-dose salbutamol on maximal heart-rate in patients with COPD following therapeutic doses of inhaled QAB149 and salmeterol
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
- 24
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
- •- Male and female patients aged 40 to 75 years of age with a diagnostics of COPD according to GOLD criteria and >10-pack year history of smoking, a post bronchodilator FEV1 < 90% of predicted and > 0.75 L, and post- bronchodilator FEV1/FVC < 70%. This criterion for FEV1 and FEV1/FVC must be demonstrated after a washout period of at least 6 h for short-acting bronchodilators, 48 h for long-acting beta-2-agonists and 72 h for antocholinergic agents.
- •For German sites only: the range for inclusion will be 40 to 65 years of age.
- •-No significant medical condition or concomitant medication that in the opinion of the investigator may compromise patient safety, patient compliance, interfere with evaluations, or preclude completion of the trial.
- •- Ability to perform standardize exercise protocol on cycle ergomter.
- •- Use of only short-acting inhaled beta2 agonists or short acting inhaled anti-cholinergics as needed to relieve COPD symptoms is permitted. Patients taking long-acting inhaled muscarinic antagonists may participate, if they are switched to short-acting inhaled beta2 agonists at least 48hours prior to screening and each study drug administration.
- •- Prior to administration of any study procedures, patients must provide written informed consent.
- •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
- •- Treatments for COPD and allied conditions: The following medications (not listed here) should NOT be allowed unless they have been stabilized for one month prior to screening.
- •- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations.
- •- Donation or loss of 400ml or more of blood within 8 weeks prior to dosing.
- •- Significant illness within six weeks prior to dosing.
- •- Medical or family history of prolonged QT-interval syndrome, or prolonged QT-interval at screening.
- •- History of clinically significant drug allergy or history of atopic allergy. Known hypersensitivity to study drugs or drugs similar to study drug.
- •- History of immunodefiency diseases
- •- A positive Hepatitis B surface antigen or Hepatitis C test result.
- •- History of drug or alcohol abuse within the 12 months prior to dosing.
- •- Unable ischemic heart disease.
- •- History of myocardial infarction
- •- Angina related to exertion.
- •- Vulnerable individuals
研究者
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