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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372462
• Other study ID #: CP-00-0035
• Status: Completed
• Phase: N/A
• First received: June 7, 2011
• Last updated: June 5, 2012
• Start date: July 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Breathe Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Breathe Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Logarithmic EMG amplitudes	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.	Study day 2	No
Primary	Tidal volume	Mean differences with and without use of the BT-NIOV™ system and, with and without the use of supplemental oxygen.	Study day 3	No
Primary	Thoracic to abdominal synchrony, as measured by respiratory inductance plethysmography.	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.	Study day 1,2 and 3	No
Secondary	SpO2 and TcPCO2	Mean differences with and without use of the BT-NIOV™ system and, with and without the use of supplemental oxygen.	Study day 1,2 and 3	No
Secondary	Pulmonary ventilation and carbon dioxide output at iso-time (the time of termination in the shortest constant work rate test for each subject)	Mean differences with and without use of the BT-NIOV™ system and, with and without the use of supplemental oxygen.	Study day 1,2 and 3	No
Secondary	Exercise duration for constant work rate exercise tests	Mean differences with and without use of the BT-NIOV™ system and, with and without the use of supplemental oxygen.	Study day 1,2 and 3	No
Secondary	Patient dyspnea and comfort scores	Mean differences with and without use of the BT-NIOV™ system and, with and without the use of supplemental oxygen.	Study day 1,2 and 3	No
Secondary	Arterialized hand-vein PCO2, and pH	Mean differences with and without use of the BT-NIOV™ system and, with and without the use of supplemental oxygen.	Study day 3	No
Secondary	Exhaled gas measurements	The following data will be collected electronically.; Minute ventilation; Dead space to tidal volume ratio; Dead space; CO2 output	Study day 3	No