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

Primary Purpose

COPD, Chronic Obstructive Pulmonary Disease

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

AIR-AD

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Moderate to severe COPD (by ATS criteria)

FEV1/FVC <0.70
FEV1 < 60% Predicted

Exclusion Criteria:

Physical limitation that prevents walking for 6 minutes (e.g. lower extremity amputation, arthritis limiting function, significant angina, etc…)
Lung pathology not explained by COPD, which may limit functional capacity (e.g. pulmonary fibrosis, malignancy, history of lung reduction surgery, etc…)
Pregnancy
Age <18

Sites / Locations

John Hansen-FlaschenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part 1: Feasibility

Part 2: Crossover

Arm Description

Patients will perform 6-minute walk test with AIR-AD to allow for observation and real-time feedback.

Crossover design where investigator will compare wearing of AIR-AD during exercise to compare distance walked with and without it.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03531489

First Posted

April 16, 2018

Last Updated

May 8, 2018

Sponsor

Right-Air

Collaborators

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT03531489

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 26, 2018 (Actual)

Primary Completion Date

December 30, 2018 (Anticipated)

Study Completion Date

December 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Right-Air

Collaborators

University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part 1: Feasibility

Arm Type

Experimental

Arm Description

Patients will perform 6-minute walk test with AIR-AD to allow for observation and real-time feedback.

Arm Title

Part 2: Crossover

Arm Type

Experimental

Arm Description

Crossover design where investigator will compare wearing of AIR-AD during exercise to compare distance walked with and without it.

Intervention Type

Device

Intervention Name(s)

AIR-AD

Intervention Description

Non-significant risk medical device as decided by institutional review board

Primary Outcome Measure Information:

Title

Assess distance travelled during 6-minute walk tests performed with and without device.

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Assess for patient improvement in shortness of breath scores

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. Moderate to severe COPD (by ATS criteria) FEV1/FVC <0.70 FEV1 < 60% Predicted Exclusion Criteria: Physical limitation that prevents walking for 6 minutes (e.g. lower extremity amputation, arthritis limiting function, significant angina, etc…) Lung pathology not explained by COPD, which may limit functional capacity (e.g. pulmonary fibrosis, malignancy, history of lung reduction surgery, etc…) Pregnancy Age <18

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Escobar

Phone

215-349-5023

escobarm@pennmedicine.upenn.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Perry Dubin, MD/MPH

Phone

6105172053

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Hansen-Flaschen, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

John Hansen-Flaschen

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Escobar

Phone

215-349-5023

escobarm@pennmedicine.upenn.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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