NCT03282019已完成不适用
Efficacy and Safety of Long-term High-flow Nasal Cannula Oxygen Therapy in Stable COPD Patients with Home Oxygen Therapy (HOT): a Multicenter, Prospective, Randomized Controlled Study
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年9月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Frequency (the number of occurrences per year) of COPD exacerbation (Moderate or Severe)
研究概览
简要总结
This is a prospective, randomized parallel study for evaluation of the efficacy and safety of long-term nocturnal high-flow nasal cannula therapy (HFNC: with the myAIRVO2 as HFNC in this study) in stable COPD patients with the global initiative for chronic obstructive lung disease (GOLD) stage 2-4, PaCO2 >= 45 Torr and hypercapnia who require home oxygen therapy (HOT) using COPD exacerbation (Moderate or Severe).
详细描述
An abroad study of the stable COPD patients was reported that HFNC usage decreased the frequency of COPD exacerbation.
In addition, the result of the pilot study (NCT02545855) of the stable COPD patient in Japan is indicated that HOT with HFNC improved their QOL and PaCO2 by comparing to HOT only.
Therefore, this study is planned to indicate the efficacy of HFNC which can increase the ventilation efficiency and have the function of heated humidification, by comparing HOT with HFNC to HOT only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed with the global initiative on obstructive lung disease (GOLD) stage 2-4 COPD.
- •Patients who have received nocturnal HOT 16 hours or more per day for 1 month or more at the time of the informed consent.
- •Patients with PaCO2 >= 45 Torr and pH >= 7.35 at screening.
- •Patients with COPD exacerbation (Moderate or Severe; judged by the investigators) within the past 1 year prior to the informed consent.
- •Patients who are more than 40 years old at the time of the informed consent.
- •Patients who agree to participate in the study with the written informed consent.
排除标准
- •Patients with severe kidney, liver or cardiovascular disease.
- •Patients with active malignant tumor.
- •Patients with acute disease.
- •Patients who are diagnosed with asthma. (Excluding COPD patients with history of asthma).
- •Patients who have any history of obstructive sleep apnea syndrome (OSAS) or are highly-suspected cases in the clinical. (Excluding patients who are denied the diagnosis of OSAS by the result of overnight polysomnography.)
- •Patients with diseases that affecting the efficacy endpoints (for example: active pulmonary infection, clinically significant pulmonary fibrosis and bronchiectasis, α-1-antitrypsin deficiency etc.,) and are regarded as inadequate for the study by the investigators.
- •Patients who have experienced a COPD exacerbation (any Severity: judged by the investigators) within the past 4 weeks prior to the informed consent.
- •Patients who are receiving nocturnal noninvasive positive pressure ventilation (NPPV), or who had been received it within 4 weeks prior to the informed consent.
- •Patients who have used HFNC at home within the past 1 year prior to the informed consent, or are using any HFNC. (Excluding patients who used HFNC during hospitalization due to acute respiratory failure within 1 year prior to the informed consent.)
- •Patients with history of tracheotomy, severe pharyngeal surgery or severe nasal cavity surgery within the past 6 months prior to the informed consent.
- •Patients who are pregnant.
- •Patients with cognitive impairment or mental disorder who are regarded as inadequate to evaluate for the study by the investigators.
- •Patients who are regarded as being unable to operate the myAIRVO2 adequately at home by the investigators.
- •Patients who have participated in the other study at the time of the informed consent, or will participate in the other study.
- •Any other cases who are regarded as inadequate for the study enrollment by the investigators.
结局指标
主要结局
Frequency (the number of occurrences per year) of COPD exacerbation (Moderate or Severe)
时间窗: 52weeks
COPD exacerbation will be assessed by the disease diary which is kept by each patient within the term of intervention.
次要结局
- Total PSQI-J(Japanese version of the Pittsburgh Sleep Quality Index) score(at 0, 12, 24 and 52 weeks)
- Oxygen Saturation (SpO2)(52weeks)
- Term from enrollment to death from any cause(up to 52 weeks)
- Frequency (the number of occurrences per year) of COPD exacerbation (All Severity and Severe only)(52weeks)
- Total SRI (Severe Respiratory Insufficiency Questionnaire) score(at 0, 12, 24 and 52 weeks)
- Term from enrollment to the date of first COPD exacerbation (Moderate or Severe)(up to 52 weeks)
- Quality-adjusted life year (QALY) by mapping the EQ-5D-5L utility scores(at 0, 12, 24 and 52 weeks)
- 6-minute walk test (6MWT)(at 0, 12, 24 and 52 weeks)
- Total St. George's respiratory questionnaire (SGRQ-C) score, and each components score (symptom score, activity score, and impact score)(at 0, 12, 24 and 52 weeks)
- Arterial blood gas analysis (ABG): pH, PaO2, PaCO2, HCO3-, BE(52weeks)
- Dyspnea intensity: the modified medical research council (mMRC) score(52weeks)
- Pulmonary functions: FVC, FEV1, FEV1%(52weeks)
- Adverse events(52weeks)
- Term from enrollment to the date of long-term (more than 1month) NPPV(Noninvasive Positive Pressure Ventilation) usage(52weeks)
- Flow rate(Oxygen / Total) (Arm A only)(52weeks)
- Total hours of myAIRVO2-use (Arm A only)(52weeks)
研究者
研究点 (2)
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