Home COPD and Open Ventilation Evaluation (HOPE) Study

This will be a single-center, open-label, pilot study in 10 stable COPD subjects to assess the ventilatory efficacy of the Life2000 Ventilation System, as compared to a control group. Other important secondary endpoints as listed in this document will also be measured and reported. Prospective participants are all current participants in the ongoing CATCH program study. Subjects will be randomized to either continued monitoring alone or monitoring with the use of the Life2000 Ventilation System for a period of six months.

Initial BODE Index (BMI, airway Obstruction, Dyspnea, Exercise intolerance), CO2 (carbon dioxide) measurements, and questionnaires and surveys are captured prior to therapy initiation. Thereafter, subjects will be randomly assigned to the Life2000 Ventilation System or their routine plan of care, as determined previously by the CATCH program, and followed for a period of six months. Both end tidal CO2 readings and the Physical Activity Scale for the Elderly (PASE) results will be captured at pre-assigned intervals during the study. Monthly phone assessments will be conducted with the subjects to track progress. An additional BODE Index measurement will be taken at Day 90, the study mid-point. At the end of six months, all baseline procedures and questionnaires will be repeated and the subject will be discharged from the study.

Inclusion criteria

• Enrollment in the CATCH Study program

• Adults 40 years and older, as per inclusion criteria of the CATCH study
• Subjects with diagnosis of COPD (with and without chronic respiratory failure)
• Gold 3 & 4
• Ability and willingness to correctly execute and comply with study requirements

o Ability and willingness to use the Life2000 Ventilation System a minimum of 6 hours/day (24 hr period).

• Requirement of supplemental oxygen to maintain an SpO2 > 88% at rest or during exercise
• Acceptable health status as assessed by medical history and/or physical exam
• Fluency in written and spoken English language
• Provision of written informed consent to participate in the study

Exclusion criteria

• History of pneumothorax secondary to lung bullae

• Musculoskeletal or other non-pulmonary impairment that limits exercise tolerance
• Intolerance or unwillingness to utilize the Life2000 Ventilation System
• Women who are pregnant or nursing a child
• 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