- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03531489
Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients
May 8, 2018 updated by: Right-Air
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
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.
|
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.
|
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.
Time Frame: 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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess for patient improvement in shortness of breath scores
Time Frame: 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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: John Hansen-Flaschen, MD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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