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

Right-Air

Status: Unknown

Conditions: Chronic Obstructive Pulmonary Disease; COPD

Treatments: Device: AIR-AD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03531489

Penn 826372

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Moderate to severe COPD (by ATS criteria)

2. FEV1/FVC <0.70

3. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Part 1: Feasibility

Experimental group

Description:

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

Treatment:

Device: AIR-AD

Part 2: Crossover

Experimental group

Description:

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

Treatment:

Device: AIR-AD