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

August 18, 2016 updated by: Breathe Technologies, Inc.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90502
        • Harbor-UCLA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • Cannula
No Intervention: No treatment
Control arm. Subjects exercise without using supplemental oxygen or NIOV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Breathe Technologies, Inc.

Investigators

  • Principal Investigator: Richard Casaburi, Ph.D., M.D., Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

June 7, 2011

First Submitted That Met QC Criteria

June 10, 2011

First Posted (Estimate)

June 14, 2011

Study Record Updates

Last Update Posted (Estimate)

October 12, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-00-0035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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