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

NCT03531489 | Unknown FDA Device

• 1 other identifier: Penn 826372
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assess for patient improvement in shortness of breath scores

  6 months

Study Arms (2)

Part 1: Feasibility

EXPERIMENTAL

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

Device: AIR-AD

Part 2: Crossover

EXPERIMENTAL

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

Device: AIR-AD

Interventions

AIR-AD DEVICE

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

Part 1: Feasibility; Part 2: Crossover

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Moderate to severe COPD (by ATS criteria)
• FEV1/FVC \<0.70
• FEV1 \< 60% Predicted

You may not qualify if:

• 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

Sponsors & Collaborators

• Right-Air: lead
• University of Pennsylvania: collaborator

Study Sites (1)

John Hansen-Flaschen

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John Hansen-Flaschen, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Escobar

CONTACT

215-349-5023; escobarm@pennmedicine.upenn.edu

Perry Dubin, MD/MPH

CONTACT

6105172053

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 21, 2018
• Study Start: April 26, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: May 21, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)