NL-OMON45687已完成4 期
A 24-week treatment, multi-center, randomized, double-blind, double-dummy, parallel group study to compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in subjects with chronic obstructive pulmonary disease (COPD) - 201749
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •* Males and females 40 years and above.
- •* COPD based on ATS/ERS current guidelines.
- •* Current and former smokers with a cigarette smoking history of *10 pack years. See protocol page 27 for details.
- •* Female participants of childbearing potential who agrees to follow the contraceptive guidance page 27-28 of the protocol.
排除标准
- •* Asthma, alpha-1-antitrypsin deficiency or other relevant respiratory disorder, see protocol page 28 for details.
- •* Unstable liver disease or unstable or life threatening cardiac disease, see protocol page 28-29 for details.
- •* Subjects with medical conditions such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy, or bladder neck obstruction, unless, in the opinion of the study physician, the benefit outweighs the risk.
- •* Hospitalization for COPD or pneumonia within 12 weeks prior to screening.
- •* Had received ICS or ICS/LABA for COPD in the 6 weeks prior to screening.
- •* Had >1 moderate exacerbation in the 12 months prior to screening, or 1 severe exacerbation requiring hospitalisation in the 12 months prior screening.
- •* Respiratory tract infection <7 days prior to screening.
- •* Use of the medications mentioned on page 30 of the protocol according to the defined time intervals prior to screening.
- •* Unable to read and/or not able to complete questionnaires on the electronic diary.
研究者
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