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

NCT01372462 | Completed Results

• 1 other identifier: CP-00-0035
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Ventilator; Constant work rate

Outcome Measures

Primary Outcomes (1)

• Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions

  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 Outcomes (2)

• SpO2 During Constant Workrate Exercise at Isotime

  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

  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

Study Arms (4)

NIOV - Room air

EXPERIMENTAL

Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).

Device: NIOV - Room Air

NIOV - Oxygen

EXPERIMENTAL

Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).

Device: NIOV - Oxygen

Nasal Cannula Oxygen

ACTIVE COMPARATOR

Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).

Device: Nasal Cannula Oxygen

No treatment

NO INTERVENTION

Control arm. Subjects exercise without using supplemental oxygen or NIOV.

Interventions

NIOV - Room Air DEVICE

Noninvasive ventilation with device powered by compressed room air.

Also known as: NIOV

NIOV - Room air

NIOV - Oxygen DEVICE

Noninvasive ventilation with device powered by compressed medical (100%) oxygen.

Also known as: NIOV

NIOV - Oxygen

Nasal Cannula Oxygen DEVICE

Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen.

Also known as: Cannula

Nasal Cannula Oxygen

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Breathe Technologies, Inc.: lead

Study Sites (1)

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Cannula

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Results Point of Contact

• Title: Richard J. Morishige, MS, RRT
• Organization: Clinical Research Consulting

rjmorishige@gmail.com

510-606-0375

Study Officials

• Richard Casaburi, Ph.D., M.D.

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 14, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 12, 2016
• Results First Posted: October 12, 2016

Record last verified: 2016-08

Locations

US (1)