AIRVO Device Intervention for Moderate to Severe COPD

Sponsor

Renown Health (Other)

Overall Status

Terminated

CT.gov ID

NCT04576936

Collaborator

Fisher and Paykel Healthcare (Industry)

Enrollment

Location

Arm

11.4

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
COPD COPD Exacerbation	Other: AIRVO	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

AIRVO Device Intervention for Moderate to Severe COPD - Pilot Study

Actual Study Start Date :

Jan 15, 2021

Actual Primary Completion Date :

Dec 28, 2021

Actual Study Completion Date :

Dec 28, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Efficacy of reducing COPD exacerbations as assessed by quantity of exacerbations seen in electronic medical record [2 years]
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 [1 year]
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 [1 year]
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 [1 year]
evaluate the efficacy of daily myAirvo™2 use on respiratory function using the Six Minute Walk Test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renown Medical Group - Pulmonary & Sleep Medicine	Reno	Nevada	United States	89502

Sponsors and Collaborators

Renown Health
Fisher and Paykel Healthcare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Renown Health

ClinicalTrials.gov Identifier:

NCT04576936

Other Study ID Numbers:

1659381-1

First Posted:

Oct 6, 2020

Last Update Posted:

Jan 14, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Renown Health

AIRVO

Additional relevant MeSH terms:

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jan 14, 2022