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AIRVO Device Intervention for Moderate to Severe COPD (AIRVO)

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ClinicalTrials.gov Identifier: NCT04576936
Recruitment Status : Recruiting
First Posted : October 6, 2020
Last Update Posted : January 29, 2021
Sponsor:
Collaborator:
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
Farah Madhani-Lovely, Renown Health

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 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
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 15, 2023
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Alanna Jacobs, MS 775-982-6911 alanna.jacobs@renown.org
Contact: Vivian Cruz, MS 775-982-3646 vivian.cruz@renown.org

Locations
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United States, Nevada
Renown Medical Group - Pulmonary & Sleep Medicine Recruiting
Reno, Nevada, United States, 89502
Contact: Alanna Jacobs, MS    775-982-6911    alanna.jacobs@renown.org   
Contact: Vivian Cruz, MS    775-982-7478    vivian.cruz@renown.org   
Principal Investigator: Farah Madhani-Lovely, MD, MPH, MBA         
Sponsors and Collaborators
Renown Health
Fisher and Paykel Healthcare
More Information
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Responsible Party: Farah Madhani-Lovely, Medical Director Pulmonary Rehabilitation, Principal Investigator, Pulmonologist, Intensivist, Renown Health
ClinicalTrials.gov Identifier: NCT04576936    
Other Study ID Numbers: 1659381-1
First Posted: October 6, 2020    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Farah Madhani-Lovely, Renown Health:
AIRVO
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases