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myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD patients in the home - a multi-center randomized controlled trial

Recruiting

The purpose of this research is to learn if home use of high flow nasal therapy (HFNT) increases the time to rehospitalization for people with chronic obstructive pulmonary disease (COPD). Participants will be randomly (by chance; like the flip of a coin) assigned to one of two groups. One group will receive usual medical care for COPD. The other group will receive usual medical care for COPD and use a high-flow nasal therapy device for a minimum of 8 hours daily. Participants will complete daily COPD symptom reports. This research will last for at least 12 months and up to 24 months.

I'm interested

Male or Female
18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• at least 30 years old
• history of a severe COPD requiring hospitalization in the previous six weeks
• specific requirements for FEV1 and FVC (study staff will review)
• current smokers must refrain from smoking when using supplemental oxygen or the myAirvo-3 device
• women of reproductive are are required to use highly effective contraception for at least 1 month prior to starting the study and agree to use such a method during study participation
• able to read and communicate in English
Exclusion Criteria:

• current use of positive airway pressure (PAP) therapy; continuous positive airway pressure (CPAP), or non-invasive positive pressure ventilation (NPPV)
• women who are pregnant or breast feeding
• recent upper airway surgery (within the previous month)
• recent head or neck trauma (within the previous month)
• require oxygen greater than at 15 L/min
• inability to tolerate nasal prongs

Respiratory System

COPD

Catherine Larson - sund0033@umn.edu
Nathaniel Gaeckle
Phase III
SITE00001599
See this study on ClinicalTrials.gov

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