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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531489
Recruitment Status : Unknown
Verified May 2018 by Right-Air.
Recruitment status was:  Recruiting
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Right-Air

Study Description
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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.

Condition or disease Intervention/treatment Phase
COPD Chronic Obstructive Pulmonary Disease Device: AIR-AD Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot, Single Center Study of Ambulatory Respiratory Assist Device in Chronic Obstructive Pulmonary Disease Patients
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531489


Contacts
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Contact: Maria Escobar 215-349-5023 escobarm@pennmedicine.upenn.edu
Contact: Perry Dubin, MD/MPH 6105172053

Locations
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United States, Pennsylvania
John Hansen-Flaschen Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maria Escobar    215-349-5023    escobarm@pennmedicine.upenn.edu   
Sponsors and Collaborators
Right-Air
University of Pennsylvania
Investigators
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Principal Investigator: John Hansen-Flaschen, MD University of Pennsylvania
More Information
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Responsible Party: Right-Air
ClinicalTrials.gov Identifier: NCT03531489    
Other Study ID Numbers: Penn 826372
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases