Pulmonary Disease, Chronic ObstructiveNCT01347931
In-home Evaluation of a Noninvasive Open Ventilation System in Patients With Severe Respiratory Insufficiency
A study testing NIOV System and Standard Oxygen Cannula in people with Pulmonary Disease, Chronic Obstructive and Airflow Obstruction, Chronic, run by Breathe Technologies, Inc. at 1 site in United States.
Trial summary
The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system will accomplish this by providing oxygen under pressure and augmenting the subject's spontaneous tidal volumes. 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?
- NIOV System and Standard Oxygen Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Mar 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female subjects, 21-80 years of age
- Diagnosis of chronic respiratory insufficiency including COPD and interstitial lung disease
- Requires use of continuous nasal oxygen of at least 2 lpm
- Reports limitation of activity due to fatigue or breathlessness
- Fluent in written and spoken English language
- Ability to be properly fitted with the Breathe nasal mask
Show all 10Show fewer
- Ability to tolerate and be appropriately titrated on the Breathe ventilator
- Ability to communicate self-assessment of dyspnea, comfort, and fatigue
- Ability and willingness to participate in the study including walking and other activities of daily living
- Ability to provide written informed consent
Who cannot join
- Recent history of frequent or severe epistaxis
- Symptoms of acute respiratory exacerbation within 48 hours of Study Day 1
- Discharge from the hospital within 30 days of study enrollment
- Subjects, who in the opinion of the Investigator, are not suitable candidates for enrollment or who are unlikely to be able to comply with trial requirements
- Subjects with conditions that, in the Investigator's opinion, contraindicates study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
Official title: In-home Evaluation of the Breathe Technologies Noninvasive Open Ventilation (NIOV™) System in Patients With Severe Respiratory Insufficiency
The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system will accomplish this by providing oxygen under pressure and augmenting the subject's spontaneous tidal volumes. The combination of efficient oxygen delivery, assisted ventilation, and a comfortable low-profile device, will result in a mean improvement in perceived well-being and ability to perform ADLs, as measured by patient-reported outcome (PRO) instruments.
Read the detailed description
This will be a prospective, open-label, crossover study in up to 12 stable subjects with chronic respiratory insufficiency who require LTOT. Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator system during selected activities of daily living. Subjects will participate in the study for up to 9 home visits, with Visits 1 and 2 each lasting for approximately 4 hours, and Visits 3-9 lasting approximately 1-2 hours each. Subjects may discontinue study participation at any time.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Airflow Obstruction, Chronic, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease
- Being tested
- NIOV System, Standard Oxygen Cannula
- 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 SystemDevice
Also called NIOV, Oxygen, O2
Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
Standard Oxygen CannulaDevice
Also called Cannula
Supplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder
| Study group | Role | What they receive |
|---|---|---|
| NIOV System | Experimental | Noninvasive ventilation and oxygen delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder Receives: Device: NIOV System |
| Standard Oxygen Therapy | Active comparator | Supplemental oxygen using standard oxygen cannula connected to a portable oxygen cylinder. Receives: Device: Standard Oxygen Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity Endurance Time
Time in minutes of sustained activity while using test treatments
Measured: Measured during single day study visit
Secondary outcomes (2)
Arterial Oxygen Saturation
O2 saturation measured by pulse oximetry
Measured: Measured during activity testing in a single day study visit
Borg Dyspnea Score
Borg Dyspnea score is measured using a 11-point visual analog scale. The lower the score on the scale, the less breathlessness patient experiences. The score ranges from:
0 = No breathlessness at all, representing better outcome 10 = Maximum, representing worse outcome
Measured: Measured during activity testing in a single day study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2012
- Study completionMar 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 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Breathe Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian W Carlin, MD, Principal investigator, West Penn Allegheny Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347931
- Sponsor's protocol ID
- CP-00-0034
- Status last verified
- Aug 2016
- First submitted
- 3 May 2011
- Last updated
- 11 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 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-home Evaluation of the Breathe Technologies Noninvasive Open Ventilation (NIOV™) System in Patients With Severe Respiratory Insufficiency
- ClinicalTrials.gov ID
- NCT01347931
- Acronym / sponsor ID
- CP-00-0034
- Conditions
- Pulmonary Disease, Chronic Obstructive, Airflow Obstruction, Chronic, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Breathe Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Posted 11 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Breathe NIOV™ System will reduce the work of breathing in subjects with chronic respiratory insufficiency who require long-term oxygen therapy (LTOT). The Breathe system will accomplish this by providing oxygen under pressure and augmenting the subject's spontaneous tidal volumes. The combination of efficient oxygen delivery, assisted ventilation, and a comfortable low-profile device, will result in a mean improvement in perceived well-being and ability to perform ADLs, as measured by patient-reported outcome (PRO) instruments.
Detailed description
This will be a prospective, open-label, crossover study in up to 12 stable subjects with chronic respiratory insufficiency who require LTOT. Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator system during selected activities of daily living. Subjects will participate in the study for up to 9 home visits, with Visits 1 and 2 each lasting for approximately 4 hours, and Visits 3-9 lasting approximately 1-2 hours each. Subjects may discontinue study participation at any time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIOV System | Experimental | Device: NIOV SystemNoninvasive ventilation and oxygen delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder |
| Standard Oxygen Therapy | Active comparator | Device: Standard Oxygen CannulaSupplemental oxygen using standard oxygen cannula connected to a portable oxygen cylinder. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult male and female subjects, 21-80 years of age
- Diagnosis of chronic respiratory insufficiency including COPD and interstitial lung disease
- Requires use of continuous nasal oxygen of at least 2 lpm
- Reports limitation of activity due to fatigue or breathlessness
- Fluent in written and spoken English language
Key exclusion criteria (5 listed)
- Recent history of frequent or severe epistaxis
- Symptoms of acute respiratory exacerbation within 48 hours of Study Day 1
- Discharge from the hospital within 30 days of study enrollment
- Subjects, who in the opinion of the Investigator, are not suitable candidates for enrollment or who are unlikely to be able to comply with trial requirements
- Subjects with conditions that, in the Investigator's opinion, contraindicates study participation
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 SystemAlso: NIOV, Oxygen, O2Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living. | Device | NIOV System |
| Standard Oxygen CannulaAlso: CannulaSupplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder | Device | Standard Oxygen Therapy |
Primary outcome
Activity Endurance Time
Time frame: Measured during single day study visit
Time in minutes of sustained activity while using test treatments
2 secondary outcomes
Arterial Oxygen Saturation
Time frame: Measured during activity testing in a single day study visit
Borg Dyspnea Score
Time frame: Measured during activity testing in a single day study visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
Brian W Carlin, MD principal investigator
West Penn Allegheny Health System
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 System and Standard Oxygen Cannula in people with Pulmonary Disease, Chronic Obstructive and Airflow Obstruction, Chronic, 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 10 inclusion and 5 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 11 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 11 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?
Activity Endurance Time (time frame: Measured during single day study visit). 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 11 Oct 2016.