Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Pilot, Single Center Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03531489
• Other study ID #: Penn 826372
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: May 2018
• Source: Right-Air
• Contact: Maria Escobar
• Phone: 215-349-5023
• Email: escobarm[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• AIR-AD
Non-significant risk medical device as decided by institutional review board

Locations

Country	Name	City	State
United States	John Hansen-Flaschen	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Right-Air	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess distance travelled during 6-minute walk tests performed with and without device.	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.	6 months
Secondary	Assess for patient improvement in shortness of breath scores	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.	6 months