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In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency

This study has been completed.
Information provided by (Responsible Party):
Breathe Technologies, Inc. Identifier:
First received: May 3, 2011
Last updated: August 17, 2016
Last verified: August 2016
Results First Received: March 8, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Pulmonary Disease, Chronic Obstructive
Airflow Obstruction, Chronic
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
Interventions: Device: NIOV System
Device: Standard Oxygen Cannula

  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
Standard Oxygen Therapy

Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.

Breathe NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.

Participant Flow for 2 periods

Period 1:   Standard Oxygen Therapy
    Standard Oxygen Therapy  
STARTED     30  
COMPLETED     29  
Withdrawal by Subject                 1  

Period 2:   NIOV System
    Standard Oxygen Therapy  
STARTED     29  
COMPLETED     29  

  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.
Per protocol

Reporting Groups
Overall Study Group All subjects participating in 2-way crossover design study

Baseline Measures
    Overall Study Group  
Number of Participants  
[units: participants]
[units: years]
Mean (Standard Deviation)
  72  (6.3)  
[units: participants]
Female     18  
Male     12  
Race (NIH/OMB)  
[units: participants]
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     26  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
United States     30  

  Outcome Measures
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1.  Primary:   Activity Endurance Time   [ Time Frame: Measured during single day study visit ]

2.  Secondary:   Arterial Oxygen Saturation   [ Time Frame: Measured during activity testing in a single day study visit ]

3.  Secondary:   Borg Dyspnea Score   [ Time Frame: Measured during activity testing in a single day study visit ]

  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 Reseach Consulting
phone: 510-606-0375

Responsible Party: Breathe Technologies, Inc. Identifier: NCT01347931     History of Changes
Other Study ID Numbers: CP-00-0034
Study First Received: May 3, 2011
Results First Received: March 8, 2015
Last Updated: August 17, 2016
Health Authority: United States: Food and Drug Administration