AIRVO Device Intervention for Moderate to Severe COPD

NCT ID: NCT04576936

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2021-12-28

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.

Conditions

COPD; COPD Exacerbation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

AIRVO

Intervention Type: OTHER

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

Interventions

AIRVO

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: collaborator

Renown Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Renown Medical Group - Pulmonary & Sleep Medicine

Reno, Nevada, United States

Countries

United States

Other Identifiers

1659381-1

Identifier Type: -

Identifier Source: org_study_id