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AIRVO Device Intervention for Moderate to Severe COPD (AIRVO)

Primary Purpose

COPD, COPD Exacerbation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AIRVO
Sponsored by
Renown Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for COPD focused on measuring AIRVO

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Renown Medical Group - Pulmonary & Sleep Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AIRVO Device

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Respiratory function test results
evaluate the efficacy of daily myAirvo™2 use on respiratory function using the Six Minute Walk Test

Full Information

First Posted
September 17, 2020
Last Updated
December 28, 2021
Sponsor
Renown Health
Collaborators
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT04576936
Brief Title
AIRVO Device Intervention for Moderate to Severe COPD
Acronym
AIRVO
Official Title
AIRVO Device Intervention for Moderate to Severe COPD - Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
December 28, 2021 (Actual)
Study Completion Date
December 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renown Health
Collaborators
Fisher and Paykel Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, COPD Exacerbation
Keywords
AIRVO

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AIRVO Device
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
AIRVO
Intervention Description
Daily, at-home device use of AIRVO device in moderate to severe COPD patients.
Primary Outcome Measure Information:
Title
Efficacy of reducing COPD exacerbations as assessed by quantity of exacerbations seen in electronic medical record
Description
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
COPD Health-related Quality of Life
Description
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.
Time Frame
1 year
Title
COPD Health-related Quality of Life
Description
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.
Time Frame
1 year
Title
Respiratory function test results
Description
evaluate the efficacy of daily myAirvo™2 use on respiratory function using the Six Minute Walk Test
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Renown Medical Group - Pulmonary & Sleep Medicine
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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AIRVO Device Intervention for Moderate to Severe COPD

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