Chronic Obstructive Pulmonary Disease, COPD
Conditions
Brief summary
The study is a two-part small scale, open-label, pilot study to evaluate feasibility and proof-of-concept for a respiratory assist medical device. The study population will consist of severe Chronic Obstructive Pulmonary Disease (COPD) subjects.
Interventions
DEVICEAIR-AD
Non-significant risk medical device as decided by institutional review board
Sponsors
University of Pennsylvania
Right-Air
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Moderate to severe COPD (by ATS criteria) 1. FEV1/FVC \<0.70 2. FEV1 \< 60% Predicted
Exclusion criteria
1. Physical limitation that prevents walking for 6 minutes (e.g. lower extremity amputation, arthritis limiting function, significant angina, etc…) 2. Lung pathology not explained by COPD, which may limit functional capacity (e.g. pulmonary fibrosis, malignancy, history of lung reduction surgery, etc…) 3. Pregnancy 4. Age \<18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess distance travelled during 6-minute walk tests performed with and without device. | 6 months | Distances travelled during two six minute walk tests will be measured. Investigator will compare distance travelled with use of the device to the distance travelled without the use of the device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess for patient improvement in shortness of breath scores | 6 months | This will be be measured via survey tool Borg Scale of Dyspnea (0 - no dyspnea, through 10 - maximal dyspnea). Patient scores will be measured during exercise testing with and without the device. Improvement will be considered a lower score on the Borg Scale. |
Countries
United States
Contacts
Primary ContactMaria Escobar
Backup ContactPerry Dubin, MD/MPH
Outcome results
None listed