AIRVO Device Intervention for Moderate to Severe COPD (AIRVO)

AIRVO Device Intervention for Moderate to Severe COPD - Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: COPD; COPD Exacerbation
• Intervention / Treatment: Other: AIRVO

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89502
      • Renown Medical Group - Pulmonary & Sleep Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIRVO Device; All participants are assigned to this single-arm: Enrolled participants will be given a MyAIRVO2 Device and device stand, and asked to use their device daily, for 12 months	Other: AIRVO; Daily, at-home device use of AIRVO device in moderate to severe COPD patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of reducing COPD exacerbations as assessed by quantity of exacerbations seen in electronic medical record	evaluate the efficacy of this device on reducing the number of COPD exacerbations, and/or COPD-related emergency department (ED) visits and hospitalizations, over a 12-month period compared with the previous 12 months	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD Health-related Quality of Life	evaluate whether the use of myAirvo™2 may improve health-related quality of life (HRQoL) in COPD patients based on responses to the St. George's Respiratory Questionnaire - COPD (SGRQ-C). Higher scores on this measure indicate greater impairment.	1 year
COPD Health-related Quality of Life	evaluate whether the use of myAirvo™2 may improve health-related quality of life (HRQoL) in COPD patients based on responses to the COPD Assessment Test (CAT). Higher scores on this measure indicate greater impairment.	1 year
Respiratory function test results	evaluate the efficacy of daily myAirvo™2 use on respiratory function using the Six Minute Walk Test	1 year

Collaborators and Investigators

• Sponsor: Renown Health
• Collaborators: Fisher and Paykel Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): December 28, 2021
• Study Completion (Actual): December 28, 2021

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: AIRVO
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 1659381-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No