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myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
NCT05204888 · Temple University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home - a Multi-center Randomized Controlled Trial
About this study
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
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)
Eligibility criteria
To be eligible to participate in this study, an individual must meet all the following criteria:
1. Provision of signed and dated informed consent form
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:
An individual who meets any of the following criteria will be excluded from participation in this study:
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.
Study design
Enrollment target: 642 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-02-02
Estimated completion: 2027-03
Last updated: 2025-02-06
Interventions
Device: myAirvo3Device: Pulse oximeter
Primary outcomes
- • 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. (1 year)
Sponsor
Temple University · other
With: Fisher and Paykel Healthcare
Contacts & investigators
ContactGerard Criner, MD · contact · Gerard.Criner@tuhs.temple.edu · 215-707-8113
ContactStephanie Yerkes · contact · stephanie.yerkes@temple.edu · 215-707-2357
All locations (27)
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Honor HealthRecruiting
Scottsdale, Arizona, United States
University of Florida, JacksonvilleRecruiting
Jacksonville, Florida, United States
Alloy Clinical ResearchRecruiting
Kissimmee, Florida, United States
Reliable Research, Inc.Recruiting
Miami, Florida, United States
NewGen Health GroupRecruiting
Miami, Florida, United States
Destiny ResearchRecruiting
Palmetto Bay, Florida, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
The Iowa ClinicRecruiting
West Des Moines, Iowa, United States
University of Maryland - BaltimoreRecruiting
Baltimore, Maryland, United States
Tufts Medical CenterRecruiting
Boston, Massachusetts, United States
Lahey Hospital and Medical CenterRecruiting
Burlington, Massachusetts, United States
Henry Ford HealthRecruiting
Detroit, Michigan, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
Cincinnati VA Medical CenterRecruiting
Cincinnati, Ohio, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
Ohio State University Wexner Medical CenterRecruiting
Columbus, Ohio, United States
St. Luke's University Health NetworkRecruiting
Bethlehem, Pennsylvania, United States
Clinical Research Associates of Central PennsylvaniaRecruiting
DuBois, Pennsylvania, United States
Jeanes HospitalRecruiting
Philadelphia, Pennsylvania, United States
Temple UniversityRecruiting
Philadelphia, Pennsylvania, United States
The University of PittsburghRecruiting
Pittsburgh, Pennsylvania, United States
Respire Research InstituteRecruiting
Houston, Texas, United States
The University of Vermont Medical Center, IncRecruiting
Burlington, Vermont, United States
West Virginia Clinical and Translational Science InstituteRecruiting
Morgantown, West Virginia, United States
Ottawa Hospital Research InstituteRecruiting
Ottawa, Ontario, Canada
The Research Institute of McGill University Health CentreRecruiting
Montreal, Quebec City, Canada