Clinical trial NCT04576936: AIRVO Device Intervention for Moderate to Severe COPD
Official title: AIRVO Device Intervention for Moderate to Severe COPD - Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COPD
COPD Exacerbation
Keywords: AIRVO
Lead sponsor: Renown Health
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2020-10-06
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of reducing COPD exacerbations as assessed by quantity of exacerbations seen in electronic medical record
timeFrame: 2 years
Secondary outcomes:
measure: COPD Health-related Quality of Life
timeFrame: 1 year
measure: COPD Health-related Quality of Life
timeFrame: 1 year
measure: Respiratory function test results
timeFrame: 1 year
Other outcomes:
Locations:
city: Reno
country: United States
facility: Renown Medical Group - Pulmonary & Sleep Medicine
state: Nevada
Study officials:
References: