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: June 5, 2012
Last verified: June 2012
  Purpose

Pilot study in 10 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 ventilation system on respiratory mechanics during constant work rate exercise in subjects with severe COPD. Two healthy male control subjects will also be evaluated in orde to validate the data collection system.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Device: Breathe Technologies Noninvasive Open Ventilation (NIOV™) System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Breathe Technologies, Inc.:

Primary Outcome Measures:
  • Logarithmic EMG amplitudes [ Time Frame: Study day 2 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • SpO2 and TcPCO2 [ Time Frame: Study day 1,2 and 3 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    The following data will be collected electronically.

    • Minute ventilation
    • Dead space to tidal volume ratio
    • Dead space
    • CO2 output


Enrollment: 10
Study Start Date: July 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NIOV - Room air Device: Breathe Technologies Noninvasive Open Ventilation (NIOV™) System
Subjects will perform incremental exercises to assess and confirm their constant work rate (CWR). They will then perform randomized condition exercises at that CWR with and without supplemental oxygen for comparison.
Other Names:
  • Breathe ventilator
  • NIOV
  • Oxygen
  • O2
  • Room air
Experimental: NIOV - Oxygen Device: Breathe Technologies Noninvasive Open Ventilation (NIOV™) System
Subjects will perform incremental exercises to assess and confirm their constant work rate (CWR). They will then perform randomized condition exercises at that CWR with and without supplemental oxygen for comparison.
Other Names:
  • Breathe ventilator
  • NIOV
  • Oxygen
  • O2
  • Room air
Active Comparator: Oxygen Nasal Cannula Device: Breathe Technologies Noninvasive Open Ventilation (NIOV™) System
Subjects will perform incremental exercises to assess and confirm their constant work rate (CWR). They will then perform randomized condition exercises at that CWR with and without supplemental oxygen for comparison.
Other Names:
  • Breathe ventilator
  • NIOV
  • Oxygen
  • O2
  • Room air
No treatment
Control
Device: Breathe Technologies Noninvasive Open Ventilation (NIOV™) System
Subjects will perform incremental exercises to assess and confirm their constant work rate (CWR). They will then perform randomized condition exercises at that CWR with and without supplemental oxygen for comparison.
Other Names:
  • Breathe ventilator
  • NIOV
  • Oxygen
  • O2
  • Room air

Detailed Description:

Subjects will participate in randomized partially blinded series of exercises at their constant work rate while using the Breathe Technologies ventilation system. Subjects will be assessed for pulmonary mechanics and gas exchange during constant work rate exercise as reflected by changes in the log amplitude of respiratory muscle EMG (intercostal, scalene and diaphragm) and chest wall to abdominal synchrony as measured by respiratory inductance plethysmography. Two healthy male control subjects will be evaluated in order to validate the data collection system. The exercises will take place over 3-4 visits with each visit lasting approximately 5 hours. Subjects may discontinue study participation at any time.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Healthy Subjects

  • Adult males, ≥ 18 years of age at screening
  • Currently in good general health as assessed by medical history and cardiopulmonary physical examination
  • Willingness and ability to perform all study related procedures and tasks
  • Ability to be properly fitted with the Breathe nasal mask
  • Ability to use the Breathe ventilator system
  • Ability to be properly fitted with an exercise mask
  • Fluency in written and spoken English
  • Provision of written informed consent

Inclusion Criteria for Subjects with COPD

  • 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 for Healthy Subjects

  • History of chronic illness or medical condition(s) that in the opinion of the Principal Investigator makes the subject unsuitable for study participation
  • Use of prescription medication(s) 30 days prior to screening, except as approved by the Principal Investigator
  • Musculoskeletal or other non-pulmonary impairment that limits exercise tolerance
  • 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

Exclusion Criteria for Subjects with COPD

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372462

Locations
United States, California
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
Sponsors and Collaborators
Breathe Technologies, Inc.
Investigators
Principal Investigator: Richard Casaburi, Ph.D., M.D. Los Angeles Biomedical Research Institute
  More Information

No publications provided

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
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Breathe Technologies, Inc.:
COPD
Ventilator
Constant work rate

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 29, 2014