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Non-invasive Ventilation System in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) (PRIDE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01355978
First Posted: May 19, 2011
Last Update Posted: October 12, 2016
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.
Information provided by (Responsible Party):
Breathe Technologies, Inc.
Results First Submitted: March 7, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Pulmonary Disease, Chronic Obstructive
Airflow Obstruction, Chronic
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
Intervention: Device: Noninvasive Open Ventilation System

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Noninvasive Open Ventilation System

Portable noninvasive open ventilator & nasal interface.

Noninvasive Open Ventilation System: Noninvasive ventilation system


Participant Flow:   Overall Study
    Noninvasive Open Ventilation System
STARTED   22 
COMPLETED   18 
NOT COMPLETED   4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Adult subjects with chronic obstructive lung disease.

Reporting Groups
  Description
Noninvasive Open Ventilation System Portable noninvasive open ventilator & nasal interface. Noninvasive Open Ventilation System used during activities of daily living.

Baseline Measures
   Noninvasive Open Ventilation System 
Overall Participants Analyzed 
[Units: Participants]
 18 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   5 
>=65 years   13 
Gender 
[Units: Participants]
 
Female   9 
Male   9 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   18 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   18 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Device Tidal Volume   [ Time Frame: Periodically over six hours x 5 days ]

2.  Secondary:   Device Preference   [ Time Frame: At conclusion of subject's participation (up to two weeks) ]

3.  Secondary:   Safety and Device-related Adverse Events   [ Time Frame: Continuous from Study Day 2 through Study Day 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Richard J. Morishige, MS, RRT
Organization: Clinical Research Consuting
phone: 510-606-0374
e-mail: rjmorishige@gmail.com



Responsible Party: Breathe Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01355978     History of Changes
Other Study ID Numbers: CP-00-0031
First Submitted: May 17, 2011
First Posted: May 19, 2011
Results First Submitted: March 7, 2015
Results First Posted: October 12, 2016
Last Update Posted: October 12, 2016