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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease; COPD
• Intervention / Treatment: Device: AIR-AD

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Escobar; Phone Number: 215-349-5023; Email: escobarm@pennmedicine.upenn.edu
• Study Contact Backup: Name: Perry Dubin, MD/MPH; Phone Number: 6105172053

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • John Hansen-Flaschen
      • Contact: Maria Escobar; Phone Number: 215-349-5023; Email: escobarm@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Feasibility; Patients will perform 6-minute walk test with AIR-AD to allow for observation and real-time feedback.	Device: AIR-AD; Non-significant risk medical device as decided by institutional review board
Experimental: Part 2: Crossover; Crossover design where investigator will compare wearing of AIR-AD during exercise to compare distance walked with and without it.	Device: AIR-AD; Non-significant risk medical device as decided by institutional review board

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Right-Air
• Collaborators: University of Pennsylvania
• Investigators: Principal Investigator: John Hansen-Flaschen, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2018
• Primary Completion (Anticipated): December 30, 2018
• Study Completion (Anticipated): December 30, 2018

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Penn 826372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No