Chronic Obstructive Lung DiseaseNCT02278107
Evaluation of a Lightweight Nasal Interface and Ventilator in Patients With Respiratory Disease
A study testing Tidal Assist Ventilator System and Nasal Cannula Oxygen in people with Chronic Obstructive Lung Disease and Interstitial Lung Disease, run by New Aera, Inc.
Trial summary
A preliminary study to evaluate a new nasal interface and portable ventilator system in comparison to standard oxygen therapy in patients with severe chronic lung disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Lung Disease, Interstitial Lung Disease
- What is being tested?
- Tidal Assist Ventilator System and Nasal Cannula Oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female (> 18 years of age) with a diagnosis of severe-to-very severe chronic lung disease
- Participates in a qualified pulmonary rehabilitation program
- Requires constant flow oxygen of ≥ 2 LPM (liters per minute) during exercise
- Able and willing to sign the informed consent
- Ability to be fitted with the test nasal mask and to use the test ventilator system
Who cannot join
- Requires > 5LPM of constant flow to maintain SpO2> 90% during exercise
- Reports having serious epistaxis within the last 14 days prior to enrollment
- Currently enrolled in another clinical study or has participated within 30 days of enrollment
- Has any condition or abnormality that in the opinion of the Investigators may compromise the participant's safety or the quality of the study data
About this study
Official title: Evaluation of a Lightweight Nasal Interface and Ventilator for Use by Patients With Respiratory Disease
A preliminary study to evaluate a new nasal interface and portable ventilator system in comparison to standard oxygen therapy in patients with severe chronic lung disease.
Read the detailed description
An open-label, randomized, controlled, crossover study in patients with severe chronic lung disease to evaluate exercise tolerance compared to standard nasal cannula oxygen therapy.
- Being tested
- Tidal Assist Ventilator System, Nasal Cannula Oxygen
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tidal Assist Ventilator SystemDevice
Also called TAV
Tidal volume augmentation with supplemental oxygen. Source gas options: cylinder, concentrator, wall.
Nasal Cannula OxygenDevice
Also called Standard oxygen therapy
Standard oxygen therapy delivered by nasal cannula at 2-5 lpm based on patient requirements. Source gas options: cylinder, concentrator, wall.
| Study group | Role | What they receive |
|---|---|---|
| Tidal Assist Ventilator System | Experimental | Lightweight, portable, positive pressure ventilator system with proprietary nasal interface. Ventilator is powered by compressed oxygen delivered by cylinder, concentrator, or wall source. Receives: Device: Tidal Assist Ventilator System |
| Nasal Cannula Oxygen | Active comparator | Nasal Cannula Oxygen Standard nasal cannula oxygen at 2-5 liters per minute (LPM) based on patient requirement. Oxygen sources includes cylinder, concentrator, or wall source. Receives: Device: Nasal Cannula Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Endurance Time to Maximum Tolerance
Endurance measured on cycle ergometer at predetermined constant work rate. Subjects will exercise to their limit of tolerability (max effort).
Measured: Maximum exercise endurance in minutes, for both treatment arms. Two 4-hr study visits, 1 week apart. Endurance endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
Secondary outcomes (6)
Borg 10 Dyspnea Score, Subject reported
10 point Analog scale
Measured: Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
Arterial Oxygen Saturation via Pulse Oximeter (SpO2)
SpO2 measured via forehead and finger pulse oximeters
Measured: Recorded 1-2 min before and every 1 minute during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
Leg Fatigue, Subject Reported
10 point Analog scale
Measured: Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
Heart Rate
Heart rate recorded by pulse oximeters
Measured: Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
Respiratory Rate
Respiratory rate recorded by observer
Measured: Recorded 1-2 min before and every 1 min during exercise. Evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
Adverse Events
Monitoring for observed or reported adverse reactions
Measured: Two 4-hr study visits, sheduled 1 week apart. Subjects will be monitored for AEs continuously throughuout the study visit. AEs will be monitored and recored during both study visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Lung 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Aera, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Kops, MD, Principal investigator, John Muir Medical Center, Concord Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278107
- Sponsor's protocol ID
- JM-001-2014
- Status last verified
- Feb 2016
- First submitted
- 23 Oct 2014
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Porszasz J, Cao R, Morishige R, van Eykern LA, Stenzler A, Casaburi R. Physiologic effects of an ambulatory ventilation system in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Aug 1;188(3):334-42. doi: 10.1164/rccm.201210-1773OC.
PubMed 23741986Hilling L, Cayou C, Kops RS, Ameo RA, Morishige RJ, Glezer S, Hill NS. Effect of a Ventilatory Assist Device in Addition to Supplemental Oxygen on Exercise Endurance in Subjects With COPD. Respir Care. 2024 Apr 22;69(5):527-533. doi: 10.4187/respcare.10875.
PubMed 38199761
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Lightweight Nasal Interface and Ventilator for Use by Patients With Respiratory Disease
- ClinicalTrials.gov ID
- NCT02278107
- Acronym / sponsor ID
- JM-001-2014
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- New Aera, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Oct 2014 (estimated)
- 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.
A preliminary study to evaluate a new nasal interface and portable ventilator system in comparison to standard oxygen therapy in patients with severe chronic lung disease.
Detailed description
An open-label, randomized, controlled, crossover study in patients with severe chronic lung disease to evaluate exercise tolerance compared to standard nasal cannula oxygen therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tidal Assist Ventilator System | Experimental | Device: Tidal Assist Ventilator SystemLightweight, portable, positive pressure ventilator system with proprietary nasal interface. Ventilator is powered by compressed oxygen delivered by cylinder, concentrator, or wall source. |
| Nasal Cannula Oxygen | Active comparator | Device: Nasal Cannula OxygenNasal Cannula Oxygen Standard nasal cannula oxygen at 2-5 liters per minute (LPM) based on patient requirement. Oxygen sources includes cylinder, concentrator, or wall source. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male or female (> 18 years of age) with a diagnosis of severe-to-very severe chronic lung disease
- Participates in a qualified pulmonary rehabilitation program
- Requires constant flow oxygen of ≥ 2 LPM (liters per minute) during exercise
- Able and willing to sign the informed consent
- Ability to be fitted with the test nasal mask and to use the test ventilator system
Key exclusion criteria (4 listed)
- Requires > 5LPM of constant flow to maintain SpO2> 90% during exercise
- Reports having serious epistaxis within the last 14 days prior to enrollment
- Currently enrolled in another clinical study or has participated within 30 days of enrollment
- Has any condition or abnormality that in the opinion of the Investigators may compromise the participant's safety or the quality of the study data
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 |
|---|---|---|
| Tidal Assist Ventilator SystemAlso: TAVTidal volume augmentation with supplemental oxygen. Source gas options: cylinder, concentrator, wall. | Device | Tidal Assist Ventilator System |
| Nasal Cannula OxygenAlso: Standard oxygen therapyStandard oxygen therapy delivered by nasal cannula at 2-5 lpm based on patient requirements. Source gas options: cylinder, concentrator, wall. | Device | Nasal Cannula Oxygen |
Primary outcome
Exercise Endurance Time to Maximum Tolerance
Time frame: Maximum exercise endurance in minutes, for both treatment arms. Two 4-hr study visits, 1 week apart. Endurance endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
Endurance measured on cycle ergometer at predetermined constant work rate. Subjects will exercise to their limit of tolerability (max effort).
6 secondary outcomes
Borg 10 Dyspnea Score, Subject reported
Time frame: Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
Arterial Oxygen Saturation via Pulse Oximeter (SpO2)
Time frame: Recorded 1-2 min before and every 1 minute during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
Leg Fatigue, Subject Reported
Time frame: Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
Heart Rate
Time frame: Recorded 1-2 min before and every 1 min during exercise testing. Two 4-hr study visits, scheduled 1 week apart. Endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
Respiratory Rate
Time frame: Recorded 1-2 min before and every 1 min during exercise. Evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.
Adverse Events
Time frame: Two 4-hr study visits, sheduled 1 week apart. Subjects will be monitored for AEs continuously throughuout the study visit. AEs will be monitored and recored during both study visits.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Background: PubMed 23741986Porszasz J, Cao R, Morishige R, van Eykern LA, Stenzler A, Casaburi R. Physiologic effects of an ambulatory ventilation system in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Aug 1;188(3):334-42. doi: 10.1164/rccm.201210-1773OC.
- Derived from this study: PubMed 38199761Hilling L, Cayou C, Kops RS, Ameo RA, Morishige RJ, Glezer S, Hill NS. Effect of a Ventilatory Assist Device in Addition to Supplemental Oxygen on Exercise Endurance in Subjects With COPD. Respir Care. 2024 Apr 22;69(5):527-533. doi: 10.4187/respcare.10875.
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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 Medical Center, Concord Campus
Questions about this trial
What is this clinical trial studying?
A study testing Tidal Assist Ventilator System and Nasal Cannula Oxygen in people with Chronic Obstructive Lung Disease and Interstitial Lung Disease, run by New Aera, Inc.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 Endurance Time to Maximum Tolerance (time frame: Maximum exercise endurance in minutes, for both treatment arms. Two 4-hr study visits, 1 week apart. Endurance endpoint will be evaluated during a single 4-hr period on Study Visit 2. Each exercise test will be separated by a 1.5 hr rest period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02278107, which also lists 2 linked publications.
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 29 Feb 2016.