Chronic Obstructive Pulmonary DiseaseNCT01372462
Effects of the Breathe Technologies Ventilation System in Subjects With Chronic Obstructive Pulmonary Disease
A study testing NIOV - Room Air, NIOV - Oxygen and Nasal Cannula Oxygen in people with Chronic Obstructive Pulmonary Disease, run by Breathe Technologies, Inc. at 1 site in United States.
Trial summary
Pilot study in 15 stable male subjects with severe-to-very severe Chronic Obstructive Pulmonary Disease (COPD) to evaluate the effects of short term use of the Breathe Technologies noninvasive open ventilation (NIOV) system on respiratory mechanics during constant work rate exercise in subjects with severe COPD. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- NIOV - Room Air, NIOV - Oxygen and Nasal Cannula Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to May 2012
- 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 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult males, ≥ 40 years of age
- Diagnosis of severe COPD (GOLD stage III or IV) defined as having a FEV1 < 50% of predicted and an FEV1/FVC ratio < 70% of predicted
- Ventilatory limitation to exercise, documented by a VE/MVV > 0.85
- SpO2 between 80% and 88% during incremental exercise testing on room air
- Willingness and ability (after training) to exercise on a cycle ergometer
- Willingness and ability to perform all other study related procedures and tasks
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- Ability to be properly fitted with the Breathe nasal mask
- Ability to tolerate and be appropriately titrated on the Breathe ventilator (See Appendix E)
- Ability to be properly fitted with an exercise mask
- Fluency in written and spoken English
- Provision of written informed consent
Who cannot join
- History of acute exacerbation of COPD within 30 days of screening
- History of serious epistaxis within 14 days of screening
- Requirement of > 5 LPM nasal O2 to maintain an SpO2 > 90% while at rest
- History of pneumothorax secondary to lung bullae
- History of intolerance to supplemental oxygen
- Musculoskeletal or other non-pulmonary impairment that limits exercise tolerance
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- Inability to achieve an optimal CWR level (4-7 minutes) during Study Visit 1R
- Current participation in another interventional study or participation within 14 days of screening
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Harbor-UCLA Medical Center
Torrance, California, 90502
About this study
Official title: A Pilot Study of the Physiologic Effects of Using the Breathe Technologies Noninvasive Open Ventilation System During Constant Work Rate Exercise in Subjects With Chronic Obstructive Pulmonary Disease
Pilot study in 15 stable male subjects with severe-to-very severe Chronic Obstructive Pulmonary Disease (COPD) to evaluate the effects of short term use of the Breathe Technologies noninvasive open ventilation (NIOV) system on respiratory mechanics during constant work rate exercise in subjects with severe COPD.
Read the detailed description
Study was a randomized double-blinded crossover design in which subjects completed a series of exercises at a constant work rate while using 1) Test noninvasive ventilation (NIOV) system powered by compressed air, 2) Test NIOV system powered by 100% oxygen, 3) nasal cannula oxygen, 4) nothing (Control). Subjects were assessed during constant work rate exercise as reflected by exercise duration, isotime oxygenation (SpO2), and isotime dyspnea score (Borg). Exercise sessions took place over 4 visits with each visit lasting approximately 5 hours.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- NIOV - Room Air, NIOV - Oxygen, Nasal Cannula Oxygen
- Keywords
- COPD, Ventilator, Constant work rate
- 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.
NIOV - Room AirDevice
Also called NIOV
Noninvasive ventilation with device powered by compressed room air.
NIOV - OxygenDevice
Also called NIOV
Noninvasive ventilation with device powered by compressed medical (100%) oxygen.
Nasal Cannula OxygenDevice
Also called Cannula
Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen.
| Study group | Role | What they receive |
|---|---|---|
| NIOV - Room air | Experimental | Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2). Receives: Device: NIOV - Room Air |
| NIOV - Oxygen | Experimental | Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2). Receives: Device: NIOV - Oxygen |
| Nasal Cannula Oxygen | Active comparator | Subjects exercise using a standard nasal cannula using medical oxygen (100% O2). Receives: Device: Nasal Cannula Oxygen |
| No treatment | No intervention | Control arm. Subjects exercise without using supplemental oxygen or NIOV. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).
Measured: Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.
Secondary outcomes (2)
SpO2 During Constant Workrate Exercise at Isotime
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).
Measured: Outcome was measured in each of the Study day 1,2, 3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxyg
Borg Dyspnea Score During Constant Workrate Exercise at Isotime
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control) at isotime. Borg Dyspnea Score ranges in values from 0 to 10. The lower score represent better outcome.
0 = No breathlessness at all, representing better outcome 10 = Maximum breathlessness, representing worse outcome
Measured: Outcome was measured in each Study day 1,2,3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and N
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2012
- Study completionMay 2012
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 Chronic Obstructive Pulmonary DiseaseStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Breathe Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Casaburi, Ph.D., M.D., Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372462
- Sponsor's protocol ID
- CP-00-0035
- Status last verified
- Aug 2016
- First submitted
- 7 Jun 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
- A Pilot Study of the Physiologic Effects of Using the Breathe Technologies Noninvasive Open Ventilation System During Constant Work Rate Exercise in Subjects With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01372462
- Acronym / sponsor ID
- CP-00-0035
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Ventilator, Constant work rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Breathe Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Jun 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.
Pilot study in 15 stable male subjects with severe-to-very severe Chronic Obstructive Pulmonary Disease (COPD) to evaluate the effects of short term use of the Breathe Technologies noninvasive open ventilation (NIOV) system on respiratory mechanics during constant work rate exercise in subjects with severe COPD.
Detailed description
Study was a randomized double-blinded crossover design in which subjects completed a series of exercises at a constant work rate while using 1) Test noninvasive ventilation (NIOV) system powered by compressed air, 2) Test NIOV system powered by 100% oxygen, 3) nasal cannula oxygen, 4) nothing (Control). Subjects were assessed during constant work rate exercise as reflected by exercise duration, isotime oxygenation (SpO2), and isotime dyspnea score (Borg). Exercise sessions took place over 4 visits with each visit lasting approximately 5 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NIOV - Room air | Experimental | Device: NIOV - Room AirSubjects exercise using the NIOV device powered by compressed air (room air, 21% O2). |
| NIOV - Oxygen | Experimental | Device: NIOV - OxygenSubjects exercise using the NIOV device powered by compressed medical oxygen (100% O2). |
| Nasal Cannula Oxygen | Active comparator | Device: Nasal Cannula OxygenSubjects exercise using a standard nasal cannula using medical oxygen (100% O2). |
| No treatment | No intervention | –Control arm. Subjects exercise without using supplemental oxygen or NIOV. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult males, ≥ 40 years of age
- Diagnosis of severe COPD (GOLD stage III or IV) defined as having a FEV1 < 50% of predicted and an FEV1/FVC ratio < 70% of predicted
- Ventilatory limitation to exercise, documented by a VE/MVV > 0.85
- SpO2 between 80% and 88% during incremental exercise testing on room air
- Willingness and ability (after training) to exercise on a cycle ergometer
Key exclusion criteria (9 listed)
- History of acute exacerbation of COPD within 30 days of screening
- History of serious epistaxis within 14 days of screening
- Requirement of > 5 LPM nasal O2 to maintain an SpO2 > 90% while at rest
- History of pneumothorax secondary to lung bullae
- History of intolerance to supplemental oxygen
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 |
|---|---|---|
| NIOV - Room AirAlso: NIOVNoninvasive ventilation with device powered by compressed room air. | Device | NIOV - Room air |
| NIOV - OxygenAlso: NIOVNoninvasive ventilation with device powered by compressed medical (100%) oxygen. | Device | NIOV - Oxygen |
| Nasal Cannula OxygenAlso: CannulaSupplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen. | Device | Nasal Cannula Oxygen |
Primary outcome
Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions
Time frame: Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.
Mean differences between NIOV - oxygen, NIOV - Room Air, Nasal Cannula Oxygen, and no treatment (control).
2 secondary outcomes
SpO2 During Constant Workrate Exercise at Isotime
Time frame: Outcome was measured in each of the Study day 1,2, 3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxyg
Borg Dyspnea Score During Constant Workrate Exercise at Isotime
Time frame: Outcome was measured in each Study day 1,2,3 and 4. Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and N
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 Casaburi, Ph.D., M.D. principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIOV - Room Air, NIOV - Oxygen and Nasal Cannula Oxygen in people with Chronic Obstructive Pulmonary Disease, run by Breathe Technologies, Inc. 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 11 inclusion and 9 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 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?
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?
Exercise Duration for Constant Work Rate Exercise Tests Under 4 Test Conditions (time frame: Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen.). 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.