A Prospective Observational Study of the Breath Responsive Variable Bolus Oxygen Conserving Device

A Study to Evaluate Improvement in the Quality of Life and Health and Economic Outcomes of Patients Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)

• Evaluate subjects in an prospective observational study

• Subjects will be administered scientifically validated questionnaires

• Evaluate Quality Improvement and Oxygen Utilization Improvements.

  1. Functional capability, dyspnea, oxygen saturation as primary endpoints

  1. Baseline Dyspnea Index (BDI)
  2. Transitional Dyspnea Index (TDI)
  3. Chronic Respiratory Disease Questionnaire (CRQ)
  4. Six minute walk distance (6MWD)
  5. Oxygen saturation using pulse oximeter

• The secondary endpoints:

  1. Portable oxygen source utilization
  2. Health care utilization (emergency room encounters, hospital admissions)

Evaluate subjects in an prospective observational study in which subjects will be screened and administered scientifically validated questionnaires at study entry and during the observation period at specified intervals to determine Quality Improvements through using the Breath Responsive Variable Bolus Oxygen Conserving Device with a Portable/Ambulatory Oxygen Source on improvements in functional capability, dyspnea, oxygen saturation, quality of life as primary endpoints, and portable oxygen source utilization, health care utilization as secondary endpoints.

Inclusion Criteria:

• Primary diagnosis of chronic obstructive pulmonary disease (COPD)
• Clinically stable disease at the time of consent
• Current prescription of oxygen 24 hours a day
• Previous or current oximetry desaturation at rest or activity (≤88% on one occasion)
• Highest measured FEV1, 70% predicted; and
• Highest measured FEV1/FVC, 70% predicted
• Capable of giving informed consent
• Currently using a portable oxygen source that is a portable tank
• Mobility without a walker, cane or rollator
• Spo2 ≥ 90% on portable oxygen source at rest and activity
• Non-smoker at time of consent

Exclusion Criteria:

• Cardiovascular disease - New York Heart Association Functional Class III
• Degenerative bone or joint disease with limited functional ability
• Current homeless persons
• Active drug/alcohol dependence
• Recent drug or alcohol abuse history within the past two years
• Clinically unstable at the time of consent
• Currently a tobacco smoker