Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator. for Chronic Obstructive Pulmonary Disease (COPD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Chronic Obstructive Pulmonary Disease (COPD)myAirvo3 - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether home High flow Nasal Therapy (HFNT) is better than usual COPD medical care for exacerbation prevention in moderate to very severe COPD patients.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: 1 year

1 year
Adverse event reporting
Correlations with average hours of use
Cost effectiveness
Dyspnea
Hospital length of stay
Moderate/severe exacerbation frequency
Quality of life - Baseline Dyspnea Index and Transitional Dyspnea Index
Quality of life - SF-12 questionnaire
Quality of life - Saint George's Respiratory Questionnaire
Quality of life - Severe Respiratory Insufficiency Questionnaire
Severe exacerbation frequency
Time to first severe exacerbation
Time to moderate or severe exacerbation
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.
pCO2 reduction

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generat...
1 of 2
Usual COPD care
1 of 2

Active Control

642 Total Participants · 2 Treatment Groups

Primary Treatment: Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator. · No Placebo Group · N/A

Usual COPD care with use of the myAirvo 3 integrated humidifier and flow generator.
Device
ActiveComparator Group · 1 Intervention: myAirvo3 · Intervention Types: Device
Usual COPD care
Device
ActiveComparator Group · 1 Intervention: Pulse oximeter · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Fisher & Paykel HealthcareUNKNOWN
Temple UniversityLead Sponsor
269 Previous Clinical Trials
73,733 Total Patients Enrolled
9 Trials studying Chronic Obstructive Pulmonary Disease (COPD)
4,384 Patients Enrolled for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to comply with all study procedures and are available for the duration of the study.
You are a male or female aged 40 years or greater.
You have a pack-year history of smoking.
You have a history of a severe COPD exacerbation requiring hospitalization in the previous six weeks.
You have had a spirometry within the previous three months.
Inhaler bronchodilators are required less than four-hourly.
You have documented moderate to very severe COPD (GOLD stages III - IV, Grade D).