NL-OMON50806已完成4 期
A randomized, multi-center, open-label, cross-over study comparing critical errors, overall errors, training/teaching time, and preference attributes of the ELLIPTA dry powder inhaler versus the BREEZHALER dry powder inhalers, in adult participants with mild to moderate asthma. - 213306 - Ellipta Device
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
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
- •Participant must be aged 18 years or older
- •Participants who have a confirmed mild or moderate asthma diagnosis
- •Participants must be on asthma maintenance therapy (ICS or ICS/LABA) for at
- •least 12 weeks prior to study participation.
- •Participants must be naïve to both the ELLIPTA and BREEZHALER inhalers
排除标准
- •Concurrent diagnosis of COPD or other respiratory disorders including active
- •tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis,
- •pulmonary hypertension, interstitial lung diseases or other active pulmonary
- •History of hypersensitivity to any components of the study inhaler (e.g.,
- •Historical or current evidence of clinically significant or rapidly progressing
- •or unstable disease that would put the safety of the participant at risk
- •through participation, or which would affect the analysis if the
- •disease/condition exacerbated during the study.
- •Participants with a known or suspected alcohol or drug abuse.
- •Any participant who is unable to read and/or would not be able to complete a
- •questionnaire and understand verbal instructions.
- •Medical and physical conditions that could impact the ability of the
- •participant to manipulate the inhaler
研究者
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