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

COPD Clinical Trial

Official title: myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home - a Multi-center Randomized Controlled Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• COPD

• NCT number: NCT05204888
• Study type: Interventional
• Source: Temple University
• Contact: Gerard Criner, MD
• Phone: 215-707-8113
• Email: Gerard.Criner@tuhs.temple.edu
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2022
• Completion date: March 2027