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

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease; COPD
• Interventions: Device: AIR-AD

• Registration Number: NCT03531489
• Lead Sponsor: Right-Air

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-16
• Study Start: 2018-04-26
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-08
• Last Update Submitted: 2018-05-08
• Study First Posted: 2018-05-21
• Last Update Posted: 2018-05-21
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 2: Crossover	AIR-AD	Crossover design where investigator will compare wearing of AIR-AD during exercise to compare distance walked with and without it.
Part 1: Feasibility	AIR-AD	Patients will perform 6-minute walk test with AIR-AD to allow for observation and real-time feedback.

Primary Outcome Measures

Name	Time	Method
Assess distance travelled during 6-minute walk tests performed with and without device.	6 months	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

Name	Time	Method
Assess for patient improvement in shortness of breath scores	6 months	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.

Trial Locations

Locations (1)

John Hansen-Flaschen; 🇺🇸 Philadelphia, Pennsylvania, United States