NCT05204888招募中不适用
MyAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home - a Multi-center Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 642
- 试验地点
- 27
- 主要终点
- To determine if myAirvo 3 use increases the time to first moderate exacerbation/severe exacerbation (hospitalization)/all-cause mortality in patients with moderate to very severe COPD.
研究概览
简要总结
Parallel-group, prospective, randomized, controlled phase III trial of home High flow Nasal Therapy (HFNT) via myAirvo 3 plus usual COPD medical care vs. usual COPD medical care, for at least 1 year and up to two years in 642 GOLD Grade D, Stages II-IV patients with moderate to very severe COPD at risk for moderate and severe exacerbations with a prior history of severe exacerbation requiring hospitalization within the past 6 weeks.
详细描述
Objectives:
Primary Objective: To determine if HFNT delivered by myAirvo 3 increases the time to first moderate exacerbation orsevere exacerbation or all-cause mortality in patients with moderate to very severe COPD
Secondary Objectives:
To determine if HFNT delivered by myAirvo 3
- increases the time to first severe exacerbation
- increases the time to first exacerbation (moderate or severe)
- reduces severe exacerbation frequency
- reduces moderate and severe exacerbation frequency
- reduces hospitalization duration
- improves quality of life
- reduces dyspnea
- reduces PCO2
- is safe and well tolerated
- determine if any of the objectives are related to duration of daily HFNT use
- Assess cost effectiveness of HFNT use
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
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in this study, an individual must meet all the following criteria:
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 30 years or greater
- •FEV1/FVC of < 70% and an FEV1 of < 80% (GOLD stages II - IV, Grade E)
- •Spirometry performed during the screening visit will be used to confirm GOLD stage. A prior spirometric test within the past 6 months can be substituted if available.
- •MRC ≥ 2 or CAT ≥ 10
- •Former smokers or current smokers and never-smokers are eligible for study inclusion
- •Current smokers must refrain from smoking when using supplemental oxygen or the myAirvo-3 device
- •History of a severe COPD exacerbation requiring hospitalization in the previous six weeks
- •COPD in a stable state after hospitalization defined as:
- •Clinically stable condition and have had no parenteral therapy for 24 hours.
- •Inhaled bronchodilators are required less than four-hourly.
- •Oxygen delivery has ceased for 24 hours (unless home oxygen is indicated).
- •If previously able, the patient is ambulating safely and independently, and performing activities of daily living.
- •The patient can eat and sleep without significant episodes of dyspnea.
- •The patient or caregiver understands and can administer medications.
- •Follow-up and home care arrangements (e.g., home oxygen, homecare, Meals on Wheels, community nurse, allied health, GP, specialist) have been completed.
- •Willing to adhere to the daily use of the myAirvo 3 regimen for at least 8 hours each day preferably at night following being shown and using the device
- •Willing to record daily symptoms and pulse oximetry and heart rate on daily basis
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
- •Highly effective contraception is defined as:
- •A tubal ligation:
- •An approved hormonal contraceptive such as oral contraceptives, emergency contraception used as directed, patches, implants, injections, rings or intrauterine devices
- •Able to read and communicate in English
- •Have a home environment suitable for myAirvo 3 use.
- •Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration - refraining from smoking while receiving supplemental oxygen or the myAirvo-3 device
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Current self-reported chronic use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
- •A STOPBang Questionnaire score > 5*
- •Pregnancy or lactation
- •Treatment with another investigational drug or other intervention within the previous 30 days
- •Life expectancy less than 12 months due to COPD or other comorbid condition.
- •Recent upper airway surgery (within the previous month)
- •Recent head or neck trauma (within the previous month)
- •Inability to tolerate nasal prongs
- •Requirement of oxygen greater than 15 L/min
- •subjects with a STOPBang questionnaire score of > 5 may be eligible if a recent sleep study (within the previous 3 months) shows the absence of obstructive sleep apnea or the subject has, or is at risk of OSA, but refuses to use an OSA device and all other eligibility criteria are met.
研究组 & 干预措施
Usual COPD care
Active Comparator
The intervention : A pulse oximeter to record heart rate and pulse oximetry on a daily basis will be provided. A smart phone and charger will also be provided to answer a short questionnaire that queries daily respiratory symptoms plus enter heart rate and pulse oximetry data
干预措施: Pulse oximeter (Device)
Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator.
Active Comparator
The intervention is the myAirvo 3 humidifier with integrated flow generator delivered through the Optiflow™ + Duet nasal cannula.
干预措施: myAirvo3 (Device)
结局指标
主要结局
To determine if myAirvo 3 use increases the time to first moderate exacerbation/severe exacerbation (hospitalization)/all-cause mortality in patients with moderate to very severe COPD.
时间窗: 1 year
Time to first moderate or severe COPD exacerbation
次要结局
- Quality of life - Severe Respiratory Insufficiency Questionnaire(1 year)
- Quality of life - Saint George's Respiratory Questionnaire(1 year)
- Dyspnea(1 year)
- pCO2 reduction(1 year)
- Adverse event reporting(1 year)
- Correlations with average hours of use(1 year)
- Time to moderate or severe exacerbation(1 year)
- Severe exacerbation frequency(1 year)
- Moderate/severe exacerbation frequency(1 year)
- Hospital length of stay(1 year)
- Quality of life - Baseline Dyspnea Index and Transitional Dyspnea Index(1 year)
- Cost effectiveness(1 year)
- Time to first severe exacerbation(1 year)
- Quality of life - SF-12 questionnaire(1 year)
研究者
研究点 (27)
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