Pulmonary Disease, Chronic ObstructiveHOPENCT03691181
Home COPD and Open Ventilation Evaluation (HOPE) Study
A study testing Ventilation in people with Pulmonary Disease, Chronic Obstructive, run by Landon Pediatric Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Ventilation
- Keywords
- Outpatient ventilator support
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentilationDevice
Also called Ambulatory
monitoring with the use of the Life2000 Ventilation System for a period of six months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- point for a dyspnea index of 2
- points for a dyspnea index of 3
- points for a dyspnea index of 4-5 E - Exercise Tolerance Values
0 point if able to walk over 349 meters
- point if able to walk 250-249 meters
- points if able to walk 150-249 meters
- points if able to walk 150 meters or less
Measured: 6 months
Secondary outcomes (5)
pre vs. on-ventilator days' change
Secondary endpoints will compare mean pre vs. on-ventilator days' differences in:
Measured: 6 months
Borg Dyspnea Scale -
Borg scale a numerical scale for assessing dyspnea, from 0 representing no dyspnea to 10 as maximal dyspnea.
Measured: prior to start of therapy, upon therapy initiation, and again at Days 1, 30, 90, and 180.
VENTILATOR USAGE
Average daily ventilator usage (acquired during monthly phone questionnaire)
Measured: Monthly for six months
PASE
Physical Activity Scale for the Elderly (PASE) - Physical Activity Scale for the Elderly (PASE) is a brief (5 minutes) and easily scored survey designed specifically to assess physical activity in epidemiological studies of persons age 65 years and older.The PASE score combines information on leisure, household and occupational activity. High Score is associated with good health.
Measured: prior to therapy initiation (baseline) and again at Days 30, 90, and 180.
HEALTH CARE COSTS
Change in healthcare utilization and costs. Examples of healthcare utilization parameters would include emergency room visits and/or hospitalizations due to exacerbations and unscheduled office visits
Measured: Six months prior to initiation and at 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study startJan 2017
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landon Pediatric Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Breathe Technologies, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691181
- Sponsor's protocol ID
- Study 210: H.O.P.E.
- Acronym
- HOPE
- Status last verified
- Sep 2018
- First submitted
- 5 Jul 2017
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home COPD and Open Ventilation Evaluation (HOPE) Study
- ClinicalTrials.gov ID
- NCT03691181
- Acronym / sponsor ID
- HOPE / Study 210: H.O.P.E.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Outpatient ventilator support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Landon Pediatric FoundationUniversity, hospital or other
- Collaborators
- Breathe Technologies, Inc.
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Ambulatory Ventilation | Experimental | Device: Ventilationmonitoring 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 |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VentilationAlso: Ambulatorymonitoring with the use of the Life2000 Ventilation System for a period of six months | Device | Open Ambulatory Ventilation |
Primary outcome
BODE Index change
Time frame: 6 months
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
5 secondary outcomes
pre vs. on-ventilator days' change
Time frame: 6 months
Borg Dyspnea Scale -
Time frame: prior to start of therapy, upon therapy initiation, and again at Days 1, 30, 90, and 180.
VENTILATOR USAGE
Time frame: Monthly for six months
PASE
Time frame: prior to therapy initiation (baseline) and again at Days 30, 90, and 180.
HEALTH CARE COSTS
Time frame: Six months prior to initiation and at 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation in people with Pulmonary Disease, Chronic Obstructive, run by Landon Pediatric Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BODE Index change (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.