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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
June 7, 2011
August 18, 2016
July 2011
May 2012   (Final data collection date for primary outcome measure)
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. ]
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).
  • Logarithmic EMG amplitudes [ Time Frame: Study day 2 ]
    Surrogate for respiratory muscle work. Mean differences with and without use of the BT-NIOV™ system and, with and without the use of supplemental oxygen.
  • Tidal volume [ Time Frame: Study day 3 ]
    Mean differences with and without use of the BT-NIOV™ system and, with and without the use of supplemental oxygen.
  • Thoracic to abdominal synchrony, as measured by respiratory inductance plethysmography. [ Time Frame: Study day 1,2 and 3 ]
    Mean differences with and without use of the BT-NIOV™ system and, with and without the use of supplemental oxygen. Data will be collected electronically on an exercise data collection system.
Complete list of historical versions of study NCT01372462 on ClinicalTrials.gov Archive Site
  • 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 ]
    Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).
  • 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 ]

    Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control) at isotime. Borg Dyspnea Score ranges in values from 0 to 10. The lower score represent better outcome.

    0 = No breathlessness at all, representing better outcome 10 = Maximum breathlessness, representing worse outcome

  • SpO2 and TcPCO2 [ Time Frame: Study day 1,2 and 3 ]
    Mean differences with and without use of the BT-NIOV™ system and, with and without the use of supplemental oxygen.
  • Pulmonary ventilation and carbon dioxide output at iso-time (the time of termination in the shortest constant work rate test for each subject) [ Time Frame: Study day 1,2 and 3 ]
    Mean differences with and without use of the BT-NIOV™ system and, with and without the use of supplemental oxygen.
  • Exercise duration for constant work rate exercise tests [ Time Frame: Study day 1,2 and 3 ]
    Mean differences with and without use of the BT-NIOV™ system and, with and without the use of supplemental oxygen.
  • Patient dyspnea and comfort scores [ Time Frame: Study day 1,2 and 3 ]
    Mean differences with and without use of the BT-NIOV™ system and, with and without the use of supplemental oxygen.
  • Arterialized hand-vein PCO2, and pH [ Time Frame: Study day 3 ]
    Mean differences with and without use of the BT-NIOV™ system and, with and without the use of supplemental oxygen.
  • Exhaled gas measurements [ Time Frame: Study day 3 ]

    The following data will be collected electronically.

    • Minute ventilation
    • Dead space to tidal volume ratio
    • Dead space
    • CO2 output
Not Provided
Not Provided
 
Effects of the Breathe Technologies Ventilation System in Subjects With Chronic Obstructive Pulmonary Disease
A Pilot Study of the Physiologic Effects of Using the Breathe Technologies Noninvasive Open Ventilation System During Constant Work Rate Exercise in Subjects With Chronic Obstructive Pulmonary Disease
Pilot study in 15 stable male subjects with severe-to-very severe Chronic Obstructive Pulmonary Disease (COPD) to evaluate the effects of short term use of the Breathe Technologies noninvasive open ventilation (NIOV) system on respiratory mechanics during constant work rate exercise in subjects with severe COPD.
Study was a randomized double-blinded crossover design in which subjects completed a series of exercises at a constant work rate while using 1) Test noninvasive ventilation (NIOV) system powered by compressed air, 2) Test NIOV system powered by 100% oxygen, 3) nasal cannula oxygen, 4) nothing (Control). Subjects were assessed during constant work rate exercise as reflected by exercise duration, isotime oxygenation (SpO2), and isotime dyspnea score (Borg). Exercise sessions took place over 4 visits with each visit lasting approximately 5 hours.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Device: NIOV - Room Air
    Noninvasive ventilation with device powered by compressed room air.
    Other Name: NIOV
  • Device: NIOV - Oxygen
    Noninvasive ventilation with device powered by compressed medical (100%) oxygen.
    Other Name: NIOV
  • Device: Nasal Cannula Oxygen
    Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen.
    Other Name: Cannula
  • Experimental: NIOV - Room air
    Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).
    Intervention: Device: NIOV - Room Air
  • Experimental: NIOV - Oxygen
    Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).
    Intervention: Device: NIOV - Oxygen
  • Active Comparator: Nasal Cannula Oxygen
    Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).
    Intervention: Device: Nasal Cannula Oxygen
  • No Intervention: No treatment
    Control arm. Subjects exercise without using supplemental oxygen or NIOV.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
May 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult males, ≥ 40 years of age
  • Diagnosis of severe COPD (GOLD stage III or IV) defined as having a FEV1 < 50% of predicted and an FEV1/FVC ratio < 70% of predicted
  • Ventilatory limitation to exercise, documented by a VE/MVV > 0.85
  • SpO2 between 80% and 88% during incremental exercise testing on room air
  • Willingness and ability (after training) to exercise on a cycle ergometer
  • Willingness and ability to perform all other study related procedures and tasks
  • Ability to be properly fitted with the Breathe nasal mask
  • Ability to tolerate and be appropriately titrated on the Breathe ventilator (See Appendix E)
  • Ability to be properly fitted with an exercise mask
  • Fluency in written and spoken English
  • Provision of written informed consent

Exclusion Criteria:

  • History of acute exacerbation of COPD within 30 days of screening
  • History of serious epistaxis within 14 days of screening
  • Requirement of > 5 LPM nasal O2 to maintain an SpO2 > 90% while at rest
  • History of pneumothorax secondary to lung bullae
  • History of intolerance to supplemental oxygen
  • Musculoskeletal or other non-pulmonary impairment that limits exercise tolerance
  • Inability to achieve an optimal CWR level (4-7 minutes) during Study Visit 1R
  • Current participation in another interventional study or participation within 14 days of screening
  • Presence of any condition or abnormality that in the opinion of the Principal Investigator may compromise the subject's safety or the quality of the study data
Sexes Eligible for Study: Male
40 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01372462
CP-00-0035
No
Not Provided
Not Provided
Breathe Technologies, Inc.
Breathe Technologies, Inc.
Not Provided
Principal Investigator: Richard Casaburi, Ph.D., M.D. Los Angeles Biomedical Research Institute
Breathe Technologies, Inc.
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP