Home COPD and Open Ventilation Evaluation (HOPE) Study

NCT03691181 | Completed DMC FDA Device

• 1 other identifier: Study 210: H.O.P.E.
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Outpatient ventilator support

Outcome Measures

Primary Outcomes (1)

• BODE Index change

  Score can range from 0 to 10. Higher score is associated with increased survival. B - Body Mass Index Values 0 points for a BMI greater than 21 1 point for a BMI less than 21 O - Airway Obstruction Values 0 points for an FEV1 greater than 64% 1 point for an FEV1 of 50-64% 2 points for an FEV1 of 36-49% 3 points for an FEV1 of less than 36% D - Dyspnea Values 0 points for a dyspnea index of 0-1 1. point for a dyspnea index of 2 2. points for a dyspnea index of 3 3. points for a dyspnea index of 4-5 E - Exercise Tolerance Values 0 point if able to walk over 349 meters 1. point if able to walk 250-249 meters 2. points if able to walk 150-249 meters 3. points if able to walk 150 meters or less

  6 months

Secondary Outcomes (5)

• pre vs. on-ventilator days' change

  6 months

• Borg Dyspnea Scale -

  prior to start of therapy, upon therapy initiation, and again at Days 1, 30, 90, and 180.

• VENTILATOR USAGE

  Monthly for six months

• PASE

  prior to therapy initiation (baseline) and again at Days 30, 90, and 180.

• HEALTH CARE COSTS

  Six months prior to initiation and at 180 days

Study Arms (1)

Open Ambulatory Ventilation

EXPERIMENTAL

monitoring with the use of the Life2000 Open Ventilation System for a period of six months with measures of nutrition, feeling of breathlessness, exercise tolerance, and quality of life. BODE Index B - BMI - BMI stands for body mass index, a calculation made by comparing height vs weight. O - Airway obstruction - Airway obstruction is measured by evaluating FEV1 - the amount of air that can be forcefully exhaled in 1 second after a deep breath. D - Dyspnea - Dyspnea refers to the degree of breathlessness someone experiences while living with COPD. E - Exercise tolerance - Exercise testing refers to how well some does on a 6-minute walk test. Modified Medical Research Council Dyspnea Scale

Device: Ventilation

Interventions

Ventilation DEVICE

monitoring with the use of the Life2000 Ventilation System for a period of six months

Also known as: Ambulatory

Open Ambulatory Ventilation

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Landon Pediatric Foundation: lead
• Breathe Technologies, Inc.: collaborator

Study Sites (1)

VCMC

Ventura, California, 93003, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: October 1, 2018
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 3, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)