Clinical trial NCT03691181: Home COPD and Open Ventilation Evaluation (HOPE) Study
Official title: Home COPD and Open Ventilation Evaluation (HOPE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Outpatient ventilator support
Lead sponsor: Landon Pediatric Foundation
Sponsor class: OTHER
Collaborators: name: Breathe Technologies, Inc.
First posted: 2018-10-01
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Respiratory related diseases such as chronic obstructive pulmonary disease (COPD) and neuromuscular diseases remain a major public health issue affecting millions of people worldwide. More than 15 million people are estimated to be diagnosed with COPD in the US alone. In the US, the direct and indirect costs associated with COPD are estimated to be about $50 billion. Clinical studies have shown that by providing ventilation to reduce respiratory insufficiency symptoms such as dyspnea, patients may become more tolerant to exercise and be able to increase their participation in activities of daily living resulting in an overall positive impact in their quality of lives. The Life2000 Ventilation System, with the smallest tubing and comfortable interface solutions, is the only ventilator to simultaneously provide full ventilatory support and enable patients to ambulate.

The Life2000 Ventilation System is an FDA-cleared critical care ventilator (K141943/S003, June 2015) indicated for use for adult patients who require positive pressure ventilation delivered invasively or non-invasively. The device, classified by FDA as a continuous ventilator, can treat both acute and chronic respiratory failure and is suitable for use in home and institutional settings by qualified, trained personnel under the direction of a physician.

The Life2000 Compressor is intended to provide a 50-psi pressure source to the ventilator and is currently in the FDA premarket notification (510 k) clearance process, so its use is considered investigational.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: BODE Index change
timeFrame: 6 months
Secondary outcomes:
measure: pre vs. on-ventilator days' change
timeFrame: 6 months
measure: Borg Dyspnea Scale -
timeFrame: prior to start of therapy, upon therapy initiation, and again at Days 1, 30, 90, and 180.
measure: VENTILATOR USAGE
timeFrame: Monthly for six months
measure: PASE
timeFrame: prior to therapy initiation (baseline) and again at Days 30, 90, and 180.
measure: HEALTH CARE COSTS
timeFrame: Six months prior to initiation and at 180 days
Other outcomes:
Locations:
city: Ventura
country: United States
facility: VCMC
state: California
Study officials:
References: