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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
  Purpose
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.

Condition Intervention
Chronic Obstructive Pulmonary Disease
Device: NIOV - Room Air
Device: NIOV - Oxygen
Device: Nasal Cannula Oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:
  • 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. ] [ Designated as safety issue: No ]
    Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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



Enrollment: 15
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
Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).
Device: NIOV - Room Air
Noninvasive ventilation with device powered by compressed room air.
Other Name: NIOV
Experimental: NIOV - Oxygen
Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).
Device: NIOV - Oxygen
Noninvasive ventilation with device powered by compressed medical (100%) oxygen.
Other Name: NIOV
Active Comparator: Nasal Cannula Oxygen
Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).
Device: Nasal Cannula Oxygen
Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen.
Other Name: Cannula
No Intervention: No treatment
Control arm. Subjects exercise without using supplemental oxygen or NIOV.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  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

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

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 December 06, 2016