EUCTR2007-003189-16-LV进行中（未招募）不适用
A randomized, multi center, parallel group, double-blind, placebo and formoterol controlled 14 day dose ranging trial 4 doses of indacaterol delivered via Twisthaler®, in patients with 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
- 558
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 adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment – see Section 6.6.5.5.)
- •-Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2006) and:
- •a) Smoking history of at least 10 pack years
- •b) Post-bronchodilator FEV1 < 80% and =30% of the predicted normal value.
- •c) Post-bronchodilator FEV1/FVC < 70%
- •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
- •-Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception.
- •-Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.
- •-Patients with a history of asthma.
- •-Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study.
- •-Other clinically significant conditions which may interfere with the study conduct or patient safety
- •as specified in the protocol.
研究者
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A randomized, multi center, parallel group, double-blind, placebo and formoterol controlled 14 day dose ranging trial of 4 doses of indacaterol delivered via Twisthaler®, in patients with COPD.Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPDEUCTR2007-003189-16-GBovartis Pharma Services AG558