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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

Tracking Information
First Submitted Date  ICMJE September 17, 2020
First Posted Date  ICMJE October 6, 2020
Last Update Posted Date January 29, 2021
Actual Study Start Date  ICMJE January 15, 2021
Estimated Primary Completion Date December 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AIRVO Device Intervention for Moderate to Severe COPD
Official Title  ICMJE AIRVO Device Intervention for Moderate to Severe COPD - Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • COPD
  • COPD Exacerbation
Intervention  ICMJE Other: AIRVO
Daily, at-home device use of AIRVO device in moderate to severe COPD patients.
Study Arms  ICMJE 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
Intervention: Other: AIRVO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2020)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2023
Estimated Primary Completion Date December 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alanna Jacobs, MS 775-982-6911 alanna.jacobs@renown.org
Contact: Vivian Cruz, MS 775-982-3646 vivian.cruz@renown.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04576936
Other Study ID Numbers  ICMJE 1659381-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Farah Madhani-Lovely, Renown Health
Study Sponsor  ICMJE Renown Health
Collaborators  ICMJE Fisher and Paykel Healthcare
Investigators  ICMJE Not Provided
PRS Account Renown Health
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP