NL-OMON44539已完成4 期
Efficacy of Single inhaler Maintenance And Reliever Therapy (SMART) with Spiromax® budesonide/formoterol versus fixed dose treatment with Diskus® fluticasone/salmeterol in COPD - SMART versus fixed dose treatment in COPD
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 260
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
- •* Age between 40 and 80 years
- •* Smoking history of > 10 pack years
- •* COPD patients with an FEV1 < 80% predicted either or not using inhaled corticosteroids.
- •* At least one COPD exacerbation for which oral prednisolone had to be prescribed during 2 years prior to inclusion in the study.
排除标准
- •* History of asthma.
- •* Exacerbation or respiratory tract infection during the last 4 weeks prior to randomization.
- •* 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 >40 mIU/mL or the use of one or more of the following acceptable methods of contraception:
- •a) Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).
- •b) Hormonal contraception (implantable, patch, oral, injectable).
- •c) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
- •d) Continuous abstinence.
- •* Periodic abstinence (e.g. calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.
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