AIRVO Device Intervention for Moderate to Severe COPD (AIRVO)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04576936 |
Recruitment Status :
Terminated
(Poor enrollment)
First Posted : October 6, 2020
Last Update Posted : January 14, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
COPD COPD Exacerbation | Other: AIRVO | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
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 : | January 15, 2021 |
Actual Primary Completion Date : | December 28, 2021 |
Actual Study Completion Date : | December 28, 2021 |

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. |
- Efficacy of reducing COPD exacerbations as assessed by quantity of exacerbations seen in electronic medical record [ Time Frame: 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
- COPD Health-related Quality of Life [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 year ]evaluate the efficacy of daily myAirvo™2 use on respiratory function using the Six Minute Walk Test

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04576936
United States, Nevada | |
Renown Medical Group - Pulmonary & Sleep Medicine | |
Reno, Nevada, United States, 89502 |
Responsible Party: | Renown Health |
ClinicalTrials.gov Identifier: | NCT04576936 |
Other Study ID Numbers: |
1659381-1 |
First Posted: | October 6, 2020 Key Record Dates |
Last Update Posted: | January 14, 2022 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
AIRVO |
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Lung Diseases Respiratory Tract Diseases |