myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
NCT ID: NCT05204888
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
642 participants
INTERVENTIONAL
2022-02-02
2027-03-31
Brief Summary
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Detailed Description
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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
1. increases the time to first severe exacerbation
2. increases the time to first exacerbation (moderate or severe)
3. reduces severe exacerbation frequency
4. reduces moderate and severe exacerbation frequency
5. reduces hospitalization duration
6. improves quality of life
7. reduces dyspnea
8. reduces PCO2
9. is safe and well tolerated
10. determine if any of the objectives are related to duration of daily HFNT use
11. Assess cost effectiveness of HFNT use
Exploratory objectives:
Develop objective definitions of exacerbations of differing levels of severity based on myAirvo 3 device or electronic diary collected measures of heart rate, respiratory rate, oxygen saturation, and dyspnea measured by modified visual analog score.
Endpoints: Primary Endpoint: The time to first moderate or severe exacerbation or all-cause mortality.
Primary Safety Endpoint: All data on adverse events, including reported to be not, possibly, probably, or definitely related to the use of myAirvo 3 device.
Secondary Endpoints:
* Rate of severe exacerbation, rate of moderate and severe exacerbations,
* Time to moderate exacerbation, time to severe exacerbation, time to moderate or severe exacerbation
* Hospitalization durations, from per visit data
* Quality of life by St George's Respiratory Questionnaire and SF-12
* Dyspnea, calculated mMRC and TDI over time
* Hours of daily HFNT use
* Impact of hours of daily HFNT use on any outcome
* PCO2
* Assess patient phenotype most likely to benefit from HFNT.
* Assess cost effectiveness of HFNT use
Exploratory endpoints:
* Development of objective definitions of exacerbations of differing levels of severity based on myAirvo 3 device or electronic diary collected measures of heart rate, respiratory rate, oxygen saturation, and dyspnea measured by modified visual analog score.
* HFNT settings (flow rate and temperature)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Patients assigned to the control group will be provided with a pulse oximetry device to record pulse oximetry and heart rate once daily after using the pulse oximeter for two minutes as well as answering a respiratory questionnaire and input data into a smartphone adapted to be used as an electronic diary.
TREATMENT
NONE
Study Groups
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Usual COPD care
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
Pulse oximeter
A pulse oximeter will be provided to measure heart rate and pulse oximetry; subjects will enter and transmit the data on the smartphone once daily before 11AM. Heart rate and pulse oximetry measures will be taken after wearing the device for approximately 2 minutes.
Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator.
The intervention is the myAirvo 3 humidifier with integrated flow generator delivered through the Optiflow™ + Duet nasal cannula.
myAirvo3
For patients assigned to the HFNT intervention group, a myAirvo 3 device will be provided. The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 - 60 L/min depending on the patient interface. The myAirvo 3 is for patients in homes and long-term care facilities.
Interventions
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myAirvo3
For patients assigned to the HFNT intervention group, a myAirvo 3 device will be provided. The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 - 60 L/min depending on the patient interface. The myAirvo 3 is for patients in homes and long-term care facilities.
Pulse oximeter
A pulse oximeter will be provided to measure heart rate and pulse oximetry; subjects will enter and transmit the data on the smartphone once daily before 11AM. Heart rate and pulse oximetry measures will be taken after wearing the device for approximately 2 minutes.
Eligibility Criteria
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Inclusion Criteria
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 30 years or greater
4. 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.
5. MRC ≥ 2 or CAT ≥ 10
6. 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
7. History of a severe COPD exacerbation requiring hospitalization in the previous six weeks
8. 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.
9. 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
10. Willing to record daily symptoms and pulse oximetry and heart rate on daily basis
11. 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
12. Able to read and communicate in English
13. Have a home environment suitable for myAirvo 3 use.
14. 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
Exclusion Criteria
1. Current self-reported chronic use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
2. A STOPBang Questionnaire score \> 5\*
3. Pregnancy or lactation
4. Treatment with another investigational drug or other intervention within the previous 30 days
5. Life expectancy less than 12 months due to COPD or other comorbid condition.
6. Recent upper airway surgery (within the previous month)
7. Recent head or neck trauma (within the previous month)
8. Inability to tolerate nasal prongs
9. 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.
30 Years
ALL
No
Sponsors
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Fisher and Paykel Healthcare
INDUSTRY
Temple University
OTHER
Responsible Party
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Locations
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UAB School of Medicine/Lung Health Center
Birmingham, Alabama, United States
Honor Health
Scottsdale, Arizona, United States
University of Florida, Jacksonville
Jacksonville, Florida, United States
Alloy Clinical Research
Kissimmee, Florida, United States
Reliable Research, Inc.
Miami, Florida, United States
NewGen Health Group
Miami, Florida, United States
Destiny Research
Palmetto Bay, Florida, United States
University of Chicago
Chicago, Illinois, United States
The Iowa Clinic
West Des Moines, Iowa, United States
University of Maryland - Baltimore
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Henry Ford Health
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States
Clinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania, United States
Jeanes Hospital
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
The University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Respire Research Institute
Houston, Texas, United States
The University of Vermont Medical Center, Inc
Burlington, Vermont, United States
West Virginia Clinical and Translational Science Institute
Morgantown, West Virginia, United States
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
The Research Institute of McGill University Health Centre
Montreal, Quebec City, Canada
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Zainab A Bhura, MBBS
Role: primary
Other Identifiers
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268447
Identifier Type: -
Identifier Source: org_study_id
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