AIRVO Device Intervention for Moderate to Severe COPD
AIRVO Device Intervention for Moderate to Severe COPD
This is an open (non-blinded), single-arm, clinical trial to assess the efficacy of daily use
 of a high-flow nasal cannula (HFNC) device in patients with moderate to severe COPD, in
 addition to standard care, in reducing the amount of COPD exacerbations over a one-year
 period. Once enrolled in the study, all subjects will be asked to undergo a baseline walking
 test to measure pulmonary function (6MWT), verify their personal and medical history
 (demographics), as well as fill in some questionnaires regarding their COPD and its symptoms
 (SGRQ-C, CAT). All subjects will then receive their own AIRVO2 device, as well as training
 and instructions on how to use the device at home. Subjects will use the MyAIRVO2 device
 daily for the following 12 months. Follow-up visits will occur five times over the 12-month
 study period and will be similar to the baseline visit. Additional data will be collected by
 the study team for each subject from their electronic medical record during the 12-month
 study enrollment period. Only information regarding COPD-related medical and/or pharmacy
 costs, specifically to measure the amount of COPD exacerbations experienced by each subject,
 will be reviewed and recorded.
Inclusion Criteria:

 -  • Moderate to severe COPD

 -  ≥2 inpatient or outpatient claims (ER, or urgent care included) in the previous
 calendar year

 -  ≥2 COPD exacerbations in previous year

 -  Current established care within the Reno/Sparks area

 -  Residing in Washoe County or Carson City County

 -  Ability to travel to site

 -  Willing to use myAirVo™2 for at least four hours per day but preferably ≥7 hours
 or overnight and be capable of handling the myAirVo™2 device after instruction

 -  Prior PFT data available prior to admission into project

 -  Understand and accept oral and written information in English

 -  Life expectancy greater than 1 year

 Exclusion Criteria:

 -  • End-stage renal disease (ESRD)

 -  Comorbidity (known malignant disease, terminal illness, dementia, uncontrolled
 mental illness, COVID-19)

 -  Oxygen requirements greater than 6 L/min

 -  Bipap or CPAP use in home

 -  Receiving hospice care

 -  PCP/PI determines the patient is not a good candidate for project inclusion

 -  Lung CA

 -  Active smoker status