Chronic Obstructive Airway DiseasePhase 1/2NCT01261377
Cardiac Hemodynamics in Overlap Syndrome (COPD With Obstructive Sleep Apnea)
A Phase 1/2 study testing Bi-level positive airway pressure (BPAP), Oxygen and CPAP in people with Chronic Obstructive Airway Disease, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
Patients with both sleep apnea and COPD have overlap syndrome, but their optimal management is not known. We plan to conduct a randomized trial of of bi-level PAP vs. night time oxygen to asses the impact of intervention on cardiac MRI and biomarkers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Airway Disease
- What is being tested?
- Bi-level positive airway pressure (BPAP), Oxygen and CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Sep 2011
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both men and women with age more than 18 years.
- Known diagnosis of COPD (GOLD stage 2 or higher).
Who cannot join
- Already using CPAP or BPAP device.
- Estimated GFR <30 ml/min/1.73 m2 or on hemodialysis.
- Women known to be pregnant or planning to be pregnant in next 6 months.
- Cardiac pacemaker, metallic heart valves, metallic implants, claustrophobic.
- Chronic atrial fibrillation or frequent premature ventricular contractions.
- Using lipid-lowering medications, aspirin, oral steroids, steroid-sparing medications or anti-oxidant vitamin supplements.
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- If taking sildenafil or related drugs, unable to stop it within 48 hours of the study visit.
- Contraindications to stress cardiac testing: acute myocardial infarction within 48 hours, unstable angina not yet stabilized with medical therapy, ongoing chest pain, active broncho-constriction, uncontrolled cardiac arrhythmia, symptomatic severe aortic stenosis, aortic dissection, acute pulmonary embolism or pericarditis.
- Uncontrolled COPD or acute COPD exacerbation.
- Known chronic inflammatory diseases like lupus or active infection.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachussets General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Comparison of Effects of Bi-level Positive Airway Pressure Therapy and Nocturnal Oxygen Therapy on Right and Left Ventricular Hemodynamics in Overlap Syndrome (Co-existent Chronic Obstructive Airway Disease and Obstructive Sleep Apnea)
Patients with both sleep apnea and COPD have overlap syndrome, but their optimal management is not known. We plan to conduct a randomized trial of of bi-level PAP vs. night time oxygen to asses the impact of intervention on cardiac MRI and biomarkers.
Read the detailed description
Presence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in the same patient has been termed overlap syndrome, affecting 1% of the U.S. population. Despite the high prevalence of overlap syndrome, little research has been done in this field. Overlap syndrome has been recently reported to have higher death rate than COPD alone, which is due to effect on the heart. However, the mechanisms by which overlap syndrome affects the heart are not known well. Also, the ideal treatment for overlap syndrome is not known.
This study is being done to find the mechanisms by which overlap syndrome affects the right and left sides of heart (using cardiac MRI to study the heart). We will also compare the effect of treatment with bi-level positive airway pressure device (BPAP) vs. night-time oxygen on heart in overlap syndrome. These aims will allow us to test the hypothesis that overlap syndrome patients have worse heart function than COPD only or OSA only, and treatment with BPAP device will improve the heart function better than oxygen only.
At the baseline visit, the subject will undergo an overnight sleep study in the hospital. In the morning, blood draw to measure serum inflammatory biomarkers (C-Reactive Protein, interleukin-6, P-selectin, ICAM-1, TNF-alpha), urine catecholamine level, six-minute walk test, questionnaire for health-related quality of life score and modified Medical Research Council (MMRC) dyspnea score, lung function tests, ultrasound of forearm blood vessels and cardiac MRI will be done. No follow-up visit is needed if the subject does not have sleep apnea. If the subject has sleep apnea based on the sleep study, he/she will be allotted to treatment with a BPAP device or night-time oxygen for 6 months. If the subject does not want to be treated with BPAP or oxygen, CPAP device will be used to treat sleep apnea. During the duration of study treatment, phone calls and a brief study visit at 3 months will be done to make sure there is no discomfort related to the treatment. After 6 months of study treatment, cardiac MRI, ultrasound of forearm blood vessels, lung function tests, blood draw for serum inflammatory biomarkers, urine catecholamine level, six-minute walk test, and questionnaires for dyspnea score and quality of life score will be repeated.
This study will help us in better understanding of mechanisms of high death rate due to effects on the heart in overlap syndrome. It will also help us in understanding better ways to treat sleep apnea in COPD patients.
- Conditions
- Chronic Obstructive Airway Disease
- Being tested
- Bi-level positive airway pressure (BPAP), Oxygen, CPAP
- Keywords
- COPD, obstructive sleep apnea, OSA, BPAP, CPAP
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Apnea, Obstructive, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-level positive airway pressure (BPAP)Device
The level of BPAP will be titrated to treat OSA as well as hypoxemia and hypercapnia. The duration of therapy will be six months.
OxygenDrug
Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.
CPAPDevice
The level of CPAP will be titrated to treat OSA. The duration of therapy will be six months.
| Study group | Role | What they receive |
|---|---|---|
| Bi-level positive airway pressure (BPAP) | Active comparator | bi-level will be titrated to optimize oxygenation and ventilation. Receives: Device: Bi-level positive airway pressure (BPAP) |
| Nocturnal oxygen | Active comparator | oxygen will be provided as per standard of care. Receives: Drug: Oxygen |
| Continuous positive airway pressure | Active comparator | The level of CPAP will be titrated to treat OSA. The duration of therapy will be six months. Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular end-diastolic volume
Measured: Six months
Secondary outcomes (6)
Other cardiac hemodynamics parameters (end-systolic volume, ejection fraction, mass index and wall motion of right and left ventricles, coronary blood flow, pulmonary artery pressure and blood flow, etc.)
Measured: Six months
Serum inflammatory biomarkers (C-reactive protein, interleukin-6, ICAM-1 and P-selectin)
Measured: Six months
Urine catecholamine level
Measured: Six months
Flow mediated dilatation of brachial artery
Measured: Six months
Pulmonary Function tests
Measured: Six months
BODE Index
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: the fellow interested in this project left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Airway DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Atul Malhotra, MD, Brigham and Women's Hospital
- Investigators
- Atul Malhotra, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261377
- Sponsor's protocol ID
- 2010-P001753
- Status last verified
- Jan 2017
- First submitted
- 15 Dec 2010
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: nothing to include
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Bi-level Positive Airway Pressure Therapy and Nocturnal Oxygen Therapy on Right and Left Ventricular Hemodynamics in Overlap Syndrome (Co-existent Chronic Obstructive Airway Disease and Obstructive Sleep Apnea)
- ClinicalTrials.gov ID
- NCT01261377
- Acronym / sponsor ID
- 2010-P001753
- Conditions
- Chronic Obstructive Airway Disease
- Keywords
- COPD, obstructive sleep apnea, OSA, BPAP, CPAP
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the fellow interested in this project left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Dec 2010 (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.
Patients with both sleep apnea and COPD have overlap syndrome, but their optimal management is not known. We plan to conduct a randomized trial of of bi-level PAP vs. night time oxygen to asses the impact of intervention on cardiac MRI and biomarkers.
Detailed description
Presence of chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) in the same patient has been termed overlap syndrome, affecting 1% of the U.S. population. Despite the high prevalence of overlap syndrome, little research has been done in this field. Overlap syndrome has been recently reported to have higher death rate than COPD alone, which is due to effect on the heart. However, the mechanisms by which overlap syndrome affects the heart are not known well. Also, the ideal treatment for overlap syndrome is not known.
This study is being done to find the mechanisms by which overlap syndrome affects the right and left sides of heart (using cardiac MRI to study the heart). We will also compare the effect of treatment with bi-level positive airway pressure device (BPAP) vs. night-time oxygen on heart in overlap syndrome. These aims will allow us to test the hypothesis that overlap syndrome patients have worse heart function than COPD only or OSA only, and treatment with BPAP device will improve the heart function better than oxygen only.
At the baseline visit, the subject will undergo an overnight sleep study in the hospital. In the morning, blood draw to measure serum inflammatory biomarkers (C-Reactive Protein, interleukin-6, P-selectin, ICAM-1, TNF-alpha), urine catecholamine level, six-minute walk test, questionnaire for health-related quality of life score and modified Medical Research Council (MMRC) dyspnea score, lung function tests, ultrasound of forearm blood vessels and cardiac MRI will be done. No follow-up visit is needed if the subject does not have sleep apnea. If the subject has sleep apnea based on the sleep study, he/she will be allotted to treatment with a BPAP device or night-time oxygen for 6 months. If the subject does not want to be treated with BPAP or oxygen, CPAP device will be used to treat sleep apnea. During the duration of study treatment, phone calls and a brief study visit at 3 months will be done to make sure there is no discomfort related to the treatment. After 6 months of study treatment, cardiac MRI, ultrasound of forearm blood vessels, lung function tests, blood draw for serum inflammatory biomarkers, urine catecholamine level, six-minute walk test, and questionnaires for dyspnea score and quality of life score will be repeated.
This study will help us in better understanding of mechanisms of high death rate due to effects on the heart in overlap syndrome. It will also help us in understanding better ways to treat sleep apnea in COPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bi-level positive airway pressure (BPAP) | Active comparator | Device: Bi-level positive airway pressure (BPAP)bi-level will be titrated to optimize oxygenation and ventilation. |
| Nocturnal oxygen | Active comparator | Drug: Oxygenoxygen will be provided as per standard of care. |
| Continuous positive airway pressure | Active comparator | Device: CPAPThe level of CPAP will be titrated to treat OSA. The duration of therapy will be six months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Both men and women with age more than 18 years.
- Known diagnosis of COPD (GOLD stage 2 or higher).
Key exclusion criteria (10 listed)
- Already using CPAP or BPAP device.
- Estimated GFR <30 ml/min/1.73 m2 or on hemodialysis.
- Women known to be pregnant or planning to be pregnant in next 6 months.
- Cardiac pacemaker, metallic heart valves, metallic implants, claustrophobic.
- Chronic atrial fibrillation or frequent premature ventricular contractions.
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 |
|---|---|---|
| Bi-level positive airway pressure (BPAP)The level of BPAP will be titrated to treat OSA as well as hypoxemia and hypercapnia. The duration of therapy will be six months. | Device | Bi-level positive airway pressure (BPAP) |
| OxygenOxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months. | Drug | Nocturnal oxygen |
| CPAPThe level of CPAP will be titrated to treat OSA. The duration of therapy will be six months. | Device | Continuous positive airway pressure |
Primary outcome
Right ventricular end-diastolic volume
Time frame: Six months
6 secondary outcomes
Other cardiac hemodynamics parameters (end-systolic volume, ejection fraction, mass index and wall motion of right and left ventricles, coronary blood flow, pulmonary artery pressure and blood flow, etc.)
Time frame: Six months
Serum inflammatory biomarkers (C-reactive protein, interleukin-6, ICAM-1 and P-selectin)
Time frame: Six months
Urine catecholamine level
Time frame: Six months
Flow mediated dilatation of brachial artery
Time frame: Six months
Pulmonary Function tests
Time frame: Six months
BODE Index
Time frame: Six months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Individual participant dataSharing planned: No. nothing to include
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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.
Atul Malhotra, MD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bi-level positive airway pressure (BPAP), Oxygen and CPAP in people with Chronic Obstructive Airway Disease, run by Brigham and Women's Hospital at 2 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 2 inclusion and 10 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: withdrawn, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Right ventricular end-diastolic volume (time frame: Six months). 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 Jan 2017.