NL-OMON44651已完成4 期
Multi-centre, randomized, double-blind, parallel-group study evaluating the effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder once daily compared with Vilanterol (VI) Inhalation Powder Once Daily on Bone Mineral Density (BMD) in subjects with Chronic Obstructive Pulmonary Disease (COPD) (HZC102972) - HZC102972
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
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 99（—）
入选标准
- •* COPD patients *40 years of age (see protocol page 16 for details).
- •* (Ex) smokers, at least 10 pack years.
- •* Pre and post salbutamol FEV1/FVC ratio <70%.
- •* Post salbutamol FEV1 *50% and *70% of predicted.
- •* At least one native hip..
- •* Safe contraception for women of childbearing potential.
排除标准
- •* Pregnancy, lactation.
- •* Bronchial asthma.
- •* Poorly controlled COPD (see protocol page 17 for details).
- •* Bone disorders (see protocol page 17 for details).
- •* Immobility.
- •* Low vitamin D (see protocol page 18 for details)
- •* Use of prohibited medication (see protocol page 19 for details).
研究者
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