NL-OMON23638尚未招募不适用
A 12-week, multicentre, randomised, double-blind, double-dummy, 2-arm parallel group study comparing the efficacy and safety of Foster® 100/6 (beclomethasone dipropionate 100 µg plus formoterol 6 µg/actuation), 2 puffs b.i.d., versus Symbicort® 200/6 (budesonide 200 µg plus formoterol 6 µg/actuation), 2 inhalations b.i.d., on parameters of small airway function in patients with Chronic Obstructive Pulmonary Disease.
CROMSOURCE – Quality System Certified ISO 9001Lange Dreef 11H, NL-4131 NJ Vianen, The Netherlands0 个研究点目标入组 144 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or when applicable written informed consent obtained by legal representative;
- •2. Outpatients with a clinical diagnosis of moderate to severe COPD and including:
排除标准
- •1. Diagnosis of asthma or other clinically or functionally relevant respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator’s opinion;
- •2. Pregnant or lactating women. Females of childbearing potential without an efficient contraception UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or are using one or more of the following acceptable methods of contraception:
研究者
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