ISRCTN60465402进行中(未招募)4 期
A longitudinal, observational study to explore the Tidal Breathing Carbon Dioxide (TBCO2) waveform, measured using the N-Tidal C device, in asthma
Cambridge Respiratory Innovations Limited0 个研究点目标入组 140 人开始时间: 2020年2月28日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 140
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
- 性别
- All
入选标准
- •1. Male or Female, aged > = 7 years
- •2. Confirmed clinician diagnosis of asthma by examination of medical records, and based on accepted national and/or international criteria e.g. BTS/SIGN, or GINA
- •3. Moderate or Severe asthma (defined as BTS stage 2-5)
- •4. Poorly controlled asthma (defined as an ACQ score of > = 1)
- •5. Exacerbation prone asthma (defined as at least 1 asthma exacerbation requiring oral corticosteroid treatment in the last 12 months)
- •6. Providing written informed consent, or parental/guardian consent and participant assent in the case of a child
排除标准
- •1. Inability to understand or comply with study procedures and/or inability to give fully informed consent
- •2. Known other lung, chest wall, neuromuscular, cardiac or other comorbidity or abnormality that would affect spirometry and/or other measures of lung function or TBCO2 measurements (including Breathing Pattern Disorder or Chronic Obstructive Pulmonary Disease)
- •3. Smokers (current or ex-smokers) with a > 10 pack-year history
- •4. In the opinion of the clinical investigator, the participant would have difficulty completing the study procedures consistently (for example, difficulty holding the device, or long periods of absence/travel) throughout the study period
研究者
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