Pulmonary Disease, Chronic ObstructivePRIDENCT01355978
Non-invasive Ventilation System in Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
A study testing Noninvasive Open Ventilation System in people with Pulmonary Disease, Chronic Obstructive and Airflow Obstruction, Chronic, run by Breathe Technologies, Inc. at 3 sites in United States.
Trial summary
When using the Breathe Technologies Ventilation System during simulated activities of daily living (ADLs), Subjects with moderate-to-severe chronic obstructive pulmonary Disease (COPD) will be comfortable and report acceptability. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Airflow Obstruction, Chronic, Chronic Obstructive Airway Disease
- What is being tested?
- Noninvasive Open Ventilation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have participated and completed the NOVEL 1 or NOVEL 2 studies.
- Be 21-80 years of age (inclusive) at time of informed consent.
- Require nasal oxygen of ≥ 2 LPM during exertion, and ≥ 1 LPM at rest.
- Exhibit dyspnea and have lung disease process dominated by COPD per the Study Investigator.
- Have a self-reported MMRC Dyspnea Score ≥ 2 on a scale of 0-4.
- Have spirometric evidence of COPD with an FEV1 of < 50% predicted and FEV1/FVC < 0.70, measured within the last 6 months (GOLD stage III and IV).
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- Have a resting respiratory rate of less than or equal to 30 bpm.
- Be fluent in reading and speaking the English language.
- Be able to clearly communicate and to indicate a self-assessment of dyspnea and/or fatigue.
- Be willing and able to participate in, and to complete all required study procedures, including the ability to pull an E-sized oxygen cylinder.
- Report having a smoking history of ≥ 10 pack-years.
- Provide written informed consent to participate in the study.
Who cannot join
- Subject must NOT meet any of the following criteria, or they will be excluded from study participation:
- Be a current tobacco smoker
- Have a history of pneumothorax in last 2 years.
- Have a history of severe, giant bullae.
- Have a history of unstable angina
- Reports the onset of cardiac arrhythmia(s) within the past 7 days.
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- Report having serious epistaxis within the last 10 days.
- Have a history of severe pulmonary hypertension and/or NYHA Stage III and IV decompensated heart failure.
- Reports symptoms of acute COPD exacerbation within the past 48 hours.
- Have been discharged from the hospital within 30 days of screening for infection or acute illness or COPD exacerbation.
- Have a prescription or history of requiring > 8 LPM oxygen during exertion.
- Have a history of serious allergic airways disease (e.g., high eosinophil count or elevated IgE).
- Report or have evidence of LVEF < 30 %
- Have a BMI > 40
- Have a history of thoracotomy, sternotomy, major cardiopulmonary intervention (e.g., lung resection, open heart surgery), or any procedure 6 months before study entry likely to cause instability of pulmonary status.
- Have a history of lung disease unrelated to smoking that affects oxygenation or survival.
- Is participating in another intervention study or have participated within 90 days of enrollment.
- Have endobronchial valves or other bronchial tree implants such as stents.
- Have a disease or condition expected to cause death, inability to perform procedures for the trial, or inability to comply with the therapy.
- Have a history of intolerance to oxygen therapy.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
John Muir Health
Concord, California, 94520
McKay-Dee Hospital Center
Ogden, Utah, 84403
Sharp Memorial Hospital
San Diego, California, 92123
About this study
Official title: Acceptability, Comfort, and Exercise Tolerance Using a Non-invasive Ventilation System in Patients With Moderate-to-Severe COPD (PRIDE)
When using the Breathe Technologies Ventilation System during simulated activities of daily living (ADLs), Subjects with moderate-to-severe chronic obstructive pulmonary Disease (COPD) will be comfortable and report acceptability.
Read the detailed description
The primary objective of the study was to evaluate the Breathe Technologies Ventilator System with regard to subject acceptability, comfort, and effect on exercise and activities of daily living tolerance.
Primary Hypothesis:
- When using the Breathe Technologies Ventilation System during simulated activities of daily living (ADL), Subjects with moderate-to-severe COPD will be comfortable and report acceptability. Secondary Hypotheses:
- When using the Breathe Technologies Ventilation System during simulated ADLs, Subjects with moderate-to-severe COPD will experience tolerable dyspnea as measured using the Borg Dyspnea Score (BDS) and a visual analog Comfort Scale (VACS).
- Subjects will prefer using the Breathe Technologies Ventilation System over standard oxygen therapy during exertion and during ADLs after using the ventilator therapy for five days.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Airflow Obstruction, Chronic, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease
- Being tested
- Noninvasive Open Ventilation System
- 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.
Noninvasive Open Ventilation SystemDevice
Noninvasive ventilation system
| Study group | Role | What they receive |
|---|---|---|
| Noninvasive Open Ventilation System | Experimental | Portable noninvasive open ventilator \& nasal interface. Receives: Device: Noninvasive Open Ventilation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Tidal Volume
Evaluate the mean test volume for three activity levels. Subjects completed five consecutive, 6-hour clinic days in which the NIOV system was worn continuously while at rest, during activities of daily living (ADLs).
Measured: Periodically over six hours x 5 days
Secondary outcomes (2)
Device Preference
5-point Likert Scale completed at the end or the 5-day study period
- Preference Scale: 5 = Max preference (Prefer to use the test device), 1 = Min preference (Do not prefer to use the test device)
Measured: At conclusion of subject's participation (up to two weeks)
Safety and Device-related Adverse Events
Any adverse events reported during he study period.
Measured: Continuous from Study Day 2 through Study Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Breathe Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Kops, MD, Principal investigator, John Muir HealthLynn McCabe, RRT, RCP, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355978
- Sponsor's protocol ID
- CP-00-0031
- Acronym
- PRIDE
- Status last verified
- Aug 2016
- First submitted
- 17 May 2011
- Last updated
- 12 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability, Comfort, and Exercise Tolerance Using a Non-invasive Ventilation System in Patients With Moderate-to-Severe COPD (PRIDE)
- ClinicalTrials.gov ID
- NCT01355978
- Acronym / sponsor ID
- PRIDE / CP-00-0031
- Conditions
- Pulmonary Disease, Chronic Obstructive, Airflow Obstruction, Chronic, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Breathe Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 May 2011 (estimated)
- Results
- Posted 12 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When using the Breathe Technologies Ventilation System during simulated activities of daily living (ADLs), Subjects with moderate-to-severe chronic obstructive pulmonary Disease (COPD) will be comfortable and report acceptability.
Detailed description
The primary objective of the study was to evaluate the Breathe Technologies Ventilator System with regard to subject acceptability, comfort, and effect on exercise and activities of daily living tolerance.
Primary Hypothesis:
- When using the Breathe Technologies Ventilation System during simulated activities of daily living (ADL), Subjects with moderate-to-severe COPD will be comfortable and report acceptability. Secondary Hypotheses:
- When using the Breathe Technologies Ventilation System during simulated ADLs, Subjects with moderate-to-severe COPD will experience tolerable dyspnea as measured using the Borg Dyspnea Score (BDS) and a visual analog Comfort Scale (VACS).
- Subjects will prefer using the Breathe Technologies Ventilation System over standard oxygen therapy during exertion and during ADLs after using the ventilator therapy for five days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noninvasive Open Ventilation System | Experimental | Device: Noninvasive Open Ventilation SystemPortable noninvasive open ventilator \& nasal interface. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have participated and completed the NOVEL 1 or NOVEL 2 studies.
- Be 21-80 years of age (inclusive) at time of informed consent.
- Require nasal oxygen of ≥ 2 LPM during exertion, and ≥ 1 LPM at rest.
- Exhibit dyspnea and have lung disease process dominated by COPD per the Study Investigator.
- Have a self-reported MMRC Dyspnea Score ≥ 2 on a scale of 0-4.
Key exclusion criteria (20 listed)
- Subject must NOT meet any of the following criteria, or they will be excluded from study participation:
- Be a current tobacco smoker
- Have a history of pneumothorax in last 2 years.
- Have a history of severe, giant bullae.
- Have a history of unstable angina
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 |
|---|---|---|
| Noninvasive Open Ventilation SystemNoninvasive ventilation system | Device | Noninvasive Open Ventilation System |
Primary outcome
Device Tidal Volume
Time frame: Periodically over six hours x 5 days
Evaluate the mean test volume for three activity levels. Subjects completed five consecutive, 6-hour clinic days in which the NIOV system was worn continuously while at rest, during activities of daily living (ADLs).
2 secondary outcomes
Device Preference
Time frame: At conclusion of subject's participation (up to two weeks)
Safety and Device-related Adverse Events
Time frame: Continuous from Study Day 2 through Study Day 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard Kops, MD principal investigator
John Muir Health
Lynn McCabe, RRT, RCP principal investigator
Sharp HealthCare
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive Open Ventilation System in people with Pulmonary Disease, Chronic Obstructive and Airflow Obstruction, Chronic, run by Breathe Technologies, Inc. at 3 sites 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 12 inclusion and 20 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 12 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 12 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Device Tidal Volume (time frame: Periodically over six hours x 5 days). 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 12 Oct 2016.