CopdNCT03522805
Impact of Non-invasive Ventilation in Hypercapnic COPD
A study testing High-intensity non-invasive ventilation in people with Copd and Chronic Obstructive Pulmonary Disease, run by University of California, San Diego at 1 site in United States.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a highly prevalent condition worldwide and is a cause of substantial morbidity and mortality. Unfortunately, few therapies have been shown to improve survival. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Copd, Chronic Obstructive Pulmonary Disease, Hypercapnia
- What is being tested?
- High-intensity non-invasive 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
- 23 Apr 2018to 21 Nov 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with previously diagnosed severe COPD (FEV1 <50% predicted) and daytime hypercapnia (PaCO2 or TcCO2 > 45 mmHg)
Who cannot join
- Lung disease besides COPD (e.g., pulmonary fibrosis, bronchiectasis, pulmonary arterial hypertension) other than well controlled asthma
- Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure
- Uncontrolled hypertension (SBP >160, DBP >95)
- Unwilling or unable to withhold CPAP during polysomnography
- Presence of tracheostomy
- Hospitalization within the past 90 days
Show all 18Show fewer
- Prior peptic ulcer disease, esophageal varicies, or gastrointestinal bleeding (< 5 years)
- Prior gastric bypass surgery
- Anticoagulant use (other than aspirin) or bleeding diathesis (only for esophageal catheter placement)
- Chronic liver disease or end-stage kidney disease
- Allergy to any of the study medications
- Regular use of medications known to affect control of breathing (opioids, benzodiazepines, theophylline)
- Insomnia or circadian rhythm disorder
- Active illicit substance use or >3 oz nightly alcohol use
- Psychiatric disease, other than controlled depression
- Pregnancy
- Prisoners
- Cognitive impairment, unable to provide consent, or unable to carry out research procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Diego
San Diego, California, 92037
About this study
Official title: Impact of Non-invasive Ventilation on Biomarkers in Hypercapnic COPD
Chronic obstructive pulmonary disease (COPD) is a highly prevalent condition worldwide and is a cause of substantial morbidity and mortality. Unfortunately, few therapies have been shown to improve survival. The importance of systemic effects and co-morbidities in COPD has garnered attention based on the observation that many patients with COPD die from causes other than respiratory failure, including a large proportion from cardiovascular causes. Recently, two high profile randomized trials have shown substantial improvements in morbidity and mortality with use of nocturnal non-invasive ventilation (NIV) in COPD patients with hypercapnia. Although the mechanisms by which NIV improves outcomes remain unclear, the important benefits of NIV might be cardiovascular via a number of mechanisms. In contrast to prior trials of NIV in COPD that did not show substantial benefit, a distinguishing feature of these encouraging recent NIV clinical trials was a prominent reduction of hypercapnia, which might be a maker or mediator of effective therapy. Alternatively, improvements might be best achieved by targeting a different physiological measure. Additional mechanistic data are therefore needed to inform future trials and achieve maximal benefit of NIV. Recent work in cardiovascular biomarkers has identified high-sensitivity troponin to have substantial ability to determine cardiovascular stress in a variety of conditions - even with only small changes. In COPD, a number of observational studies have shown that high-sensitivity troponin increases with worsening disease severity, and that levels increase overnight during sleep. This biomarker therefore presents a promising means to study causal pathways regarding the effect of NIV in patients with COPD. With this background, the investigator's overall goals are: 1) To determine whether the beneficial effect of non-invasive ventilation might be due to a reduction in cardiovascular stress, using established cardiovascular biomarkers, and 2) To define whether a reduction in PaCO2 (or alternative mechanism) is associated with such an effect.
- Conditions
- Copd, Chronic Obstructive Pulmonary Disease, Hypercapnia, Chronic Respiratory Failure, Hypoventilation
- Being tested
- High-intensity non-invasive ventilation
- Keywords
- copd, lung, non-invasive ventilation, hypercapnia, hypoventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypercapnia, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity non-invasive ventilationDevice
Single night of high-intensity non-invasive ventilation
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive ventilation | Experimental | Subjects will undergo a baseline night with standard polysomnography, followed by a treatment night using non-invasive ventilation under polysomnography Receives: Device: High-intensity non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired difference in morning level of high sensitivity troponin between baseline and NIV nights
Comparing morning levels of high sensitivity troponin between baseline and NIV nights
Measured: 1 day
Secondary outcomes (6)
Paired difference in overnight increase in high sensitivity troponin between baseline and NIV night
Troponin assay: Minimum 0, no maximum, with higher values worse.
Measured: 1 day
Paired difference in sleep quality by Richards-Campbell Sleep Questionnaire between baseline and NIV night
Questionnaire: 5 questions, 0 to 100 on visual analog scale, with higher scores indicating better sleep. Total score reported as mean of 5 components.
Measured: 1 day
Paired difference in sleep quality by arousal index between baseline and NIV night
Arousal index: Index reported as events/hour. Minimum 0, no maximum, with higher scores indicating worse sleep.
Measured: 1 day
Paired difference in heart rate variability during sleep between baseline and NIV night
Comparing difference in heart rate variability during sleep between baseline and NIV night
Measured: 1 day
Paired difference between Morning psychomotor vigilance testing score between baseline and NIV night
Psychomotor vigilance score: Reported as number of lapses. Minimum 0, no maximum, with higher values worse.
Measured: 1 day
Paired difference in morning exhaled nitric oxide level between baseline and NIV night
Exhaled nitric oxide assay: Minimum 0, no maximumm with higher values worse.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start23 Apr 2018
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Why it stopped: Failure to accrue subjects. All activity has stopped \& no analysis will be done on what has been collected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Orr, M.D., University of California, San Diego
- Investigators
- Jeremy E Orr, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522805
- Sponsor's protocol ID
- 161873
- Status last verified
- Aug 2020
- First submitted
- 1 May 2018
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-invasive Ventilation on Biomarkers in Hypercapnic COPD
- ClinicalTrials.gov ID
- NCT03522805
- Acronym / sponsor ID
- 161873
- Conditions
- Copd, Chronic Obstructive Pulmonary Disease, Hypercapnia, Chronic Respiratory Failure, Hypoventilation
- Keywords
- copd, lung, non-invasive ventilation, hypercapnia, hypoventilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to accrue subjects. All activity has stopped \& no analysis will be done on what has been collected.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 11 May 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.
Chronic obstructive pulmonary disease (COPD) is a highly prevalent condition worldwide and is a cause of substantial morbidity and mortality. Unfortunately, few therapies have been shown to improve survival. The importance of systemic effects and co-morbidities in COPD has garnered attention based on the observation that many patients with COPD die from causes other than respiratory failure, including a large proportion from cardiovascular causes. Recently, two high profile randomized trials have shown substantial improvements in morbidity and mortality with use of nocturnal non-invasive ventilation (NIV) in COPD patients with hypercapnia. Although the mechanisms by which NIV improves outcomes remain unclear, the important benefits of NIV might be cardiovascular via a number of mechanisms. In contrast to prior trials of NIV in COPD that did not show substantial benefit, a distinguishing feature of these encouraging recent NIV clinical trials was a prominent reduction of hypercapnia, which might be a maker or mediator of effective therapy. Alternatively, improvements might be best achieved by targeting a different physiological measure. Additional mechanistic data are therefore needed to inform future trials and achieve maximal benefit of NIV. Recent work in cardiovascular biomarkers has identified high-sensitivity troponin to have substantial ability to determine cardiovascular stress in a variety of conditions - even with only small changes. In COPD, a number of observational studies have shown that high-sensitivity troponin increases with worsening disease severity, and that levels increase overnight during sleep. This biomarker therefore presents a promising means to study causal pathways regarding the effect of NIV in patients with COPD. With this background, the investigator's overall goals are: 1) To determine whether the beneficial effect of non-invasive ventilation might be due to a reduction in cardiovascular stress, using established cardiovascular biomarkers, and 2) To define whether a reduction in PaCO2 (or alternative mechanism) is associated with such an effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive ventilation | Experimental | Device: High-intensity non-invasive ventilationSubjects will undergo a baseline night with standard polysomnography, followed by a treatment night using non-invasive ventilation under polysomnography |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with previously diagnosed severe COPD (FEV1 <50% predicted) and daytime hypercapnia (PaCO2 or TcCO2 > 45 mmHg)
Key exclusion criteria (18 listed)
- Lung disease besides COPD (e.g., pulmonary fibrosis, bronchiectasis, pulmonary arterial hypertension) other than well controlled asthma
- Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure
- Uncontrolled hypertension (SBP >160, DBP >95)
- Unwilling or unable to withhold CPAP during polysomnography
- Presence of tracheostomy
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 |
|---|---|---|
| High-intensity non-invasive ventilationSingle night of high-intensity non-invasive ventilation | Device | Non-invasive ventilation |
Primary outcome
Paired difference in morning level of high sensitivity troponin between baseline and NIV nights
Time frame: 1 day
Comparing morning levels of high sensitivity troponin between baseline and NIV nights
6 secondary outcomes
Paired difference in overnight increase in high sensitivity troponin between baseline and NIV night
Time frame: 1 day
Paired difference in sleep quality by Richards-Campbell Sleep Questionnaire between baseline and NIV night
Time frame: 1 day
Paired difference in sleep quality by arousal index between baseline and NIV night
Time frame: 1 day
Paired difference in heart rate variability during sleep between baseline and NIV night
Time frame: 1 day
Paired difference between Morning psychomotor vigilance testing score between baseline and NIV night
Time frame: 1 day
Paired difference in morning exhaled nitric oxide level between baseline and NIV night
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Failure to accrue subjects. All activity has stopped \& no analysis will be done on what has been collected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
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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.
Jeremy E Orr, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity non-invasive ventilation in people with Copd and Chronic Obstructive Pulmonary Disease, run by University of California, San Diego 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 1 inclusion and 18 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: stopped early, as of the sponsor's last update on 27 Aug 2020. 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 was stopped early (reason given: Failure to accrue subjects. All activity has stopped \& no analysis will be done on what has been collected.). 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?
Paired difference in morning level of high sensitivity troponin between baseline and NIV nights (time frame: 1 day). 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 27 Aug 2020.