EUCTR2011-004641-41-SE进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, multi-centre, 6-way cross-over, single-dose Phase IIa study to investigate the local and systemic effects of 3 different doses of inhaled AZD2115 compared with active comparators, in patients with chronic obstructive pulmonary disease (COPD) - AZD2115 SDXO study
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
- 36
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
- •Provision of informed consent prior to any study specific procedures
- •Male or female of non-childbearing potential (post-menopausal or surgically sterilised), age =40 years at Visit 1
- •Clinical diagnosis of COPD for more than 1 year at Visit 1, according to GOLD guidelines
- •Post-bronchodilator FEV1 = 40 to < 80% of the predicted normal value and post-bronchodilator FEV1/FVC < 70%
- •Reversible airway obstruction
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study.
- •An exacerbation of COPD within 6 weeks prior to Visit 1
- •Treatment with systemic glucocorticosteroids with 6 weeks of Visit 2.
- •Recent or ongoing respiratory tract infection during enrolment period
- •Need for long-term oxygen therapy and/or saturation O2 < 92%
研究者
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A single-dose study to investigate the effects of 3 different doses of inhaled AZD2115 in COPD patientsAZD2115 is being developed to treat chronic obstructive pulmonary disease (COPD).MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2011-004641-41-PLAstraZeneca AB36