myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home

• ClinicalTrials.gov Identifier: NCT05204888
• Recruitment Status: Recruiting
• First Posted: January 24, 2022
• Last Update Posted: January 12, 2023
• Sponsor: Temple University
• Collaborator: Fisher & Paykel Healthcare
• Information provided by (Responsible Party): Temple University

Study Description

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 III-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.

Condition or disease	Intervention/treatment	Phase
COPD	Device: myAirvo3; Device: Pulse oximeter	Not Applicable

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)

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 642 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

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.

• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home - a Multi-center Randomized Controlled Trial
• Actual Study Start Date: February 2, 2022
• Estimated Primary Completion Date: January 2027
• Estimated Study Completion Date: March 2027

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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	Device: 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.
Active Comparator: 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.	Device: 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.

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: 1 year ]
   Time to first moderate or severe COPD exacerbation

Secondary Outcome Measures :

1. Time to first severe exacerbation [ Time Frame: 1 year ]
   To determine if HFNT delivered by myAirvo 3 increases the time to first severe exacerbation
2. Time to moderate or severe exacerbation [ Time Frame: 1 year ]
   To determine if HFNT delivered by myAirvo 3 increases the time to first exacerbation (moderate or severe)
3. Severe exacerbation frequency [ Time Frame: 1 year ]
   To determine if HFNT delivered by myAirvo 3 reduces severe exacerbation frequency
4. Moderate/severe exacerbation frequency [ Time Frame: 1 year ]
   To determine if HFNT delivered by myAirvo reduces moderate and severe exacerbation frequency
5. Hospital length of stay [ Time Frame: 1 year ]
   To determine if HFNT delivered by myAirvo 3 reduces hospitalization duration
6. Quality of life - SF-12 questionnaire [ Time Frame: 1 year ]
   To determine if HFNT delivered by myAirvo improves quality of life as measured by the SF-12
7. Quality of life - Severe Respiratory Insufficiency Questionnaire [ Time Frame: 1 year ]
   To determine if HFNT delivered by myAirvo improves quality of life as measured by the Severe Respiratory Insufficiency Questionnaire
8. Quality of life - Saint George's Respiratory Questionnaire [ Time Frame: 1 year ]
   To determine if HFNT delivered by myAirvo improves quality of life as measured by the Saint George's Respiratory Questionnaire
9. Quality of life - Baseline Dyspnea Index and Transitional Dyspnea Index [ Time Frame: 1 year ]
   To determine if HFNT delivered by myAirvo improves quality of life as measured by the EQ-5D questionnaire
10. Dyspnea [ Time Frame: 1 year ]
    To determine if HFNT delivered by myAirvo reduces dyspnea as measured by the Baseline Dyspnea Index and Transitional Dyspnea Index
11. pCO2 reduction [ Time Frame: 1 year ]
    To determine if HFNT delivered by myAirvo reduces pCO2
12. Adverse event reporting [ Time Frame: 1 year ]
    To determine if HFNT delivered by myAirvo is safe and well tolerated
13. Correlations with average hours of use [ Time Frame: 1 year ]
    To determine if any of the above outcomes are related to duration of daily HFNT use
14. Cost effectiveness [ Time Frame: 1 year ]
    To assess the cost effectiveness of HFNT use in COPD

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion 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 40 years or greater
4. Documented history of moderate to very severe COPD (GOLD stages III - IV, Grade D)
5. MRC ≥ 2 or CAT ≥ 10
6. ≥ 10 pack-year history of smoking
7. History of a severe COPD exacerbation requiring hospitalization in the previous six weeks
8. Recent spirometry (within the previous three months) that shows an FEV1 post bronchodilator is < 50% predicted

9. COPD in a stable state after hospitalization defined as:

   1. Clinically stable condition and have had no parenteral therapy for 24 hours.
   2. Inhaled bronchodilators are required less than four-hourly.
   3. Oxygen delivery has ceased for 24 hours (unless home oxygen is indicated).
   4. If previously able, the patient is ambulating safely and independently, and performing activities of daily living.
   5. The patient can eat and sleep without significant episodes of dyspnea.
   6. The patient or caregiver understands and can administer medications.
   7. Follow-up and home care arrangements (e.g., home oxygen, homecare, Meals on Wheels, community nurse, allied health, GP, specialist) have been completed.
10. 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
11. Willing to record daily symptoms and pulse oximetry and heart rate on daily basis
12. 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 13. Able to read and communicate in English 14. Have a home environment suitable for myAirvo 3 use. 15. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

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 7. Recent head or neck trauma 8. Inability to tolerate nasal prongs 9. Requirement of oxygen greater than 15 L/min

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Contacts and Locations

Contacts

Contact: Gerard Criner, MD; 215-707-8113; Gerard.Criner@tuhs.temple.edu

Contact: Michael Jacobs, PharmD; 215-707-2242; Michael.jacobs@temple.edu

Locations

United States, Ohio

Cleveland Clinic Foundation; Recruiting

Cleveland, Ohio, United States, 44195

Contact: Erica Corrao, RRT, MS 216-444-0843 CORRAOE2@ccf.org

Principal Investigator: Vickram Tejwani, MD

United States, Pennsylvania

Temple University; Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contact: Lii-Yoong Criner, RN 215-707-9847 Lii-Yoong.Criner@tuhs.temple.edu

Contact: Sheril George, BS, RRT 215-707-1359 Sheril.George@tuhs.temple.edu

United States, West Virginia

West Virginia Clinical and Translational Science Institute; Recruiting

Morgantown, West Virginia, United States, 26506

Contact: Cami Handlan, RN 304-293-6360 cami.handlan@hsc.wvu.edu

Principal Investigator: Rachel Leonard, MD

Sponsors and Collaborators

Temple University

Fisher & Paykel Healthcare

More Information

• Responsible Party: Temple University
• ClinicalTrials.gov Identifier: NCT05204888
• Other Study ID Numbers: 268447
• First Posted: January 24, 2022
• Last Update Posted: January 12, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No