Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Effects of the Breathe Technologies Ventilation System in Subjects With Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Breathe Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01372462
First received: June 7, 2011
Last updated: August 18, 2016
Last verified: August 2016
Results First Received: March 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Device: NIOV - Room Air
Device: NIOV - Oxygen
Device: Nasal Cannula Oxygen

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Study Participants

All subjects completed all 4 visit days in which they were randomized to receive which treatment to receive first: 1) NIOV - Oxygen, 2) NIOV - Room Air, 3) Oxygen Nasal Cannula, 4) No treatment.

Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.


Participant Flow for 4 periods

Period 1:   NIOV - Room Air
    All Study Participants
STARTED   15 
COMPLETED   15 
NOT COMPLETED   0 

Period 2:   NIOV - Oxygen
    All Study Participants
STARTED   15 
COMPLETED   15 
NOT COMPLETED   0 

Period 3:   Oxygen Nasal Cannula
    All Study Participants
STARTED   15 
COMPLETED   15 
NOT COMPLETED   0 

Period 4:   No Treatment Control
    All Study Participants
STARTED   15 
COMPLETED   15 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
The primary endpoint is difference in endurance between cannula oxygen and NIOV+O2. Assuming 153 sec clinically important difference, 183 sec SD of increase and α=0.05, a sample size of 15 yields 85% power.

Reporting Groups
  Description
Overall Study Group Crossover design. Subject were randomized to complete all 4 study arms: 1) NIOV - Oxygen, 2) NIOV - Room Air, 3) Oxygen Nasal Cannula, 4) No treatment

Baseline Measures
   Overall Study Group 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.5  (9.1) 
Gender [1] 
[Units: Participants]
 
Female   0 
Male   15 
[1] Only male subjects were recruited due to need for placement of sensors on an exposed chest area.
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   15 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions   [ Time Frame: Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen. ]

2.  Secondary:   SpO2 During Constant Workrate Exercise at Isotime   [ Time Frame: Outcome was measured in each of the Study day 1,2, 3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxyg ]

3.  Secondary:   Borg Dyspnea Score During Constant Workrate Exercise at Isotime   [ Time Frame: Outcome was measured in each Study day 1,2,3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and N ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 Consulting
phone: 510-606-0375
e-mail: rjmorishige@gmail.com



Responsible Party: Breathe Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01372462     History of Changes
Other Study ID Numbers: CP-00-0035
Study First Received: June 7, 2011
Results First Received: March 8, 2015
Last Updated: August 18, 2016
Health Authority: United States: Food and Drug Administration