NCT04576936

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2021

Completed
Last Updated

January 14, 2022

Status Verified

December 1, 2021

Enrollment Period

12 months

First QC Date

September 17, 2020

Last Update Submit

December 28, 2021

Conditions

COPDCOPD Exacerbation

Keywords

AIRVO

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • COPD Health-related Quality of Life

    1 year

  • COPD Health-related Quality of Life

    1 year

  • Respiratory function test results

    1 year

Study Arms (1)

AIRVO Device

EXPERIMENTAL

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

Interventions

AIRVOOTHER

Daily, at-home device use of AIRVO device in moderate to severe COPD patients.

AIRVO Device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Lung CA
  • Active smoker status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renown Medical Group - Pulmonary & Sleep Medicine

Reno, Nevada, 89502, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2020

First Posted

October 6, 2020

Study Start

January 15, 2021

Primary Completion

December 28, 2021

Study Completion

December 28, 2021

Last Updated

January 14, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)