AIRVO Device Intervention for Moderate to Severe COPD

COPD Clinical Trial

— AIRVO  

Official title:

AIRVO Device Intervention for Moderate to Severe COPD - Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04576936
• Other study ID #: 1659381-1
• Status: Terminated
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: December 28, 2021

Study information

• Verified date: December 2021
• Source: Renown Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 28, 2021
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	Renown Medical Group - Pulmonary & Sleep Medicine	Reno	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
Renown Health	Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 year
Secondary	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.	1 year
Secondary	Respiratory function test results	evaluate the efficacy of daily myAirvo™2 use on respiratory function using the Six Minute Walk Test	1 year