Clinical trial NCT05204888: myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
Official title: myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home - a Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2022-01-24
Enrollment: 642
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients assigned to the HFNT group will be provided a myAirvo 3 device. The myAirvo 3 is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces. The interface used in this trial is the Optiflow™ + Duet nasal cannula sized for patient comfort. Patients will also be provided with a pulse oximetry device that connects to the myAirvo 3 to record pulse oximetry and heart rate once daily after wearing the device for two minutes.

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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Primary outcomes:
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: Time to first severe exacerbation
timeFrame: 1 year
measure: Time to moderate or severe exacerbation
timeFrame: 1 year
measure: Severe exacerbation frequency
timeFrame: 1 year
measure: Moderate/severe exacerbation frequency
timeFrame: 1 year
measure: Hospital length of stay
timeFrame: 1 year
measure: Quality of life - SF-12 questionnaire
timeFrame: 1 year
measure: Quality of life - Severe Respiratory Insufficiency Questionnaire
timeFrame: 1 year
measure: Quality of life - Saint George's Respiratory Questionnaire
timeFrame: 1 year
measure: Quality of life - Baseline Dyspnea Index and Transitional Dyspnea Index
timeFrame: 1 year
measure: Dyspnea
timeFrame: 1 year
measure: pCO2 reduction
timeFrame: 1 year
measure: Adverse event reporting
timeFrame: 1 year
measure: Correlations with average hours of use
timeFrame: 1 year
measure: Cost effectiveness
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB School of Medicine/Lung Health Center
state: Alabama
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Jacksonville
country: United States
facility: University of Florida, Jacksonville
state: Florida
city: Kissimmee,
country: United States
facility: Alloy Clinical Research
state: Florida
city: Miami
country: United States
facility: Reliable Research, Inc.
state: Florida
city: Miami
country: United States
facility: NewGen Health Group
state: Florida
city: Palmetto Bay
country: United States
facility: Destiny Research
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland - Baltimore
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: DuBois
country: United States
facility: Clinical Research Associates of Central Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jeanes Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The University of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: Respire Research Institute
state: Texas
city: Burlington
country: United States
facility: The University of Vermont Medical Center, Inc
state: Vermont
city: Morgantown
country: United States
facility: West Virginia Clinical and Translational Science Institute
state: West Virginia
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Montréal
country: Canada
facility: The Research Institute of McGill University Health Centre
state: Quebec City
Study officials:
References: