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| Name | Class |
|---|---|
| Fisher and Paykel Healthcare | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIRVO | Other | Daily, at-home device use of AIRVO device in moderate to severe COPD patients. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| COPD Health-related Quality of Life |
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Inclusion Criteria:
• Moderate to severe COPD
Exclusion Criteria:
• End-stage renal disease (ESRD)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renown Medical Group - Pulmonary & Sleep Medicine | Reno | Nevada | 89502 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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 |
| Respiratory function test results | evaluate the efficacy of daily myAirvo™2 use on respiratory function using the Six Minute Walk Test | 1 year |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |