NL-OMON46712已完成4 期
An open label, randomised, parallel group clinical study to evaluate the effect of the Connected Inhaler System (CIS) on adherence to Relvar/Breo ELLIPTA therapy, in asthmatic subjects with poor control (study 207040) - study 207040
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
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
- •* Males and females at least 18 years of age.
- •* Documented diagnosis of asthma.
- •* Asthma Control Test <20 at screening.
- •* Asthma Control Test (ACT) score <20 at randomization.
- •* Non-smokers (never smoked or not smoking for >6 months with <10 pack years history).
- •* Subject must have been on maintenance therapy (Fixed dose combination ICS/LABA) for 3 months. See protocol page 31 for details).
- •* Background asthma medication such as anti-leukotrienes and oral corticosteroids are permitted provided the dose has been stable for 1 month prior to screening.
- •* Female participants of childbearing potential should agree to follow the contraceptive guidance in appendix 5 of the protocol during the treatment period and for at least 5 days after the last dose of study treatment.
排除标准
- •* History of life-threatening asthma. See protocol page 32 for details.
- •* Lower airway infection in the last 7 days before screening.
- •* COPD or other respiratory disorders. See protocol page 32 for details.
- •* Other diseases: See protocol page 32 for details.
- •* Ever received treatment with biological based therapy.
- •* Pregnancy or lactation.
研究者
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