COPD & OSANCT00914264
The Effects of Continuous Positive Airway Pressure on Overlap Syndrome
An observational study of COPD & OSA, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
1. The first objective of this study is to determine the differences between, while the airway obstruction severity is the same, and the acute continuous positive airway pressure (CPAP) effect on chronic obstructive pulmonary disease (COPD) patients with overlap syndrome compared with COPD patients without in terms of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD & OSA
- What is being tested?
- continuous positive airway pressure
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2008to Dec 2016
- Phase
- Observational
- 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
Study population: from outpatient clinic of CGMH and those in COPD cohort
Who may be able to join
- chronic stable COPD
- FEV1/FVC < 70%
- No response to beta-agonist
- without acute exacerbation within2 months
Who cannot join
- Chronic respiratory failure (PaO2<60 mmHg, PaCO2>50 mmHg)
- Clinical evidence of congestive heart failure
- Facial defect and all the other condition that can't tolerate nasal mask
- Malignancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Thoracic Medicine, Chang Gung Memorial Hospital
Taipei, 105
About this study
Official title: The Continuous Positive Airway Pressure Effects on Chronic Obstructive Pulmonary Disease Patients With Obstructive Sleep Apnea
- The first objective of this study is to determine the differences between, while the airway obstruction severity is the same, and the acute continuous positive airway pressure (CPAP) effect on chronic obstructive pulmonary disease (COPD) patients with overlap syndrome compared with COPD patients without in terms of sleep quality, autonomic nerve activity, biologic markers of systemic inflammatory, and exercise performance.
- The second objective of this study is to evaluate the subacute (3 months treatment) CPAP effect on COPD patients with overlap syndrome in terms of pulmonary hemodynamic and right heart function, We will also determine the subacute effect of CPAP on sleep and life quality, autonomic nerve activity, biologic markers of systemic inflammatory, as well as exercise performance.
- The last objective of this study is to evaluate the long term (12 months treatment) CPAP effect on COPD patients with overlap syndrome. The un-scheduled clinic or emergency department visiting, hospitalization, or mortality will be recorded to see if there is significant treatment effect in terms of reducing morbidity and mortality. The long term CPAP effect on sleep and life quality, autonomic nerve activity, biologic markers of systemic inflammatory, exercise performance, as well as pulmonary hemodynamic and right heart function will be re-evaluation.
Read the detailed description
COPD patients will be disturbed by season 12 months follow up is better than 18 months
- Conditions
- COPD & OSA
- Being tested
- continuous positive airway pressure
- Keywords
- chronic obstructive airway disease, obstructive sleep apnea, continuous positive airway pressure
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressureDevice
CPAP with adequate pressure for 1 day, 3 \& 12 months
| Study group | Role | What they receive |
|---|---|---|
| COPD with OSA with CPAP treatment | COPD with OSA: CPAP treatment Receives: Device: continuous positive airway pressure | |
| COPD without OSA | COPD without OSA, not treat with CPAP | |
| COPD with OSA but without CPAP treatment | COPD with OSA but patient refused CPAP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise performance
the condition of COPD patient will be disturbed by season factor 12 months follow up will be better than 18 months
Measured: 3 days, 3 & 12 months
Secondary outcomes (2)
autonomic nerve activity
the same reason as above
Measured: 3 days, 3 & 12 months
mortality and acute exacerbation
Measured: 1, 5, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startDec 2008
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD & OSAStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Lun Lo, MD, Study director, Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, TaiwanTsai-Yu Wang, MD, Principal investigator, Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, TaiwanHan-Pin Kuo, MD,PHD, Study chair, Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914264
- Sponsor's protocol ID
- 972246B
- Status last verified
- Aug 2010
- First submitted
- 2 Jun 2009
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wang TY, Lo YL, Lee KY, Liu WT, Lin SM, Lin TY, Ni YL, Wang CY, Ho SC, Kuo HP. Nocturnal CPAP improves walking capacity in COPD patients with obstructive sleep apnoea. Respir Res. 2013 Jun 19;14(1):66. doi: 10.1186/1465-9921-14-66.
PubMed 23782492
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Continuous Positive Airway Pressure Effects on Chronic Obstructive Pulmonary Disease Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00914264
- Acronym / sponsor ID
- 972246B
- Conditions
- COPD & OSA
- Keywords
- chronic obstructive airway disease, obstructive sleep apnea, continuous positive airway pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Jun 2009 (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.
- The first objective of this study is to determine the differences between, while the airway obstruction severity is the same, and the acute continuous positive airway pressure (CPAP) effect on chronic obstructive pulmonary disease (COPD) patients with overlap syndrome compared with COPD patients without in terms of sleep quality, autonomic nerve activity, biologic markers of systemic inflammatory, and exercise performance.
- The second objective of this study is to evaluate the subacute (3 months treatment) CPAP effect on COPD patients with overlap syndrome in terms of pulmonary hemodynamic and right heart function, We will also determine the subacute effect of CPAP on sleep and life quality, autonomic nerve activity, biologic markers of systemic inflammatory, as well as exercise performance.
- The last objective of this study is to evaluate the long term (12 months treatment) CPAP effect on COPD patients with overlap syndrome. The un-scheduled clinic or emergency department visiting, hospitalization, or mortality will be recorded to see if there is significant treatment effect in terms of reducing morbidity and mortality. The long term CPAP effect on sleep and life quality, autonomic nerve activity, biologic markers of systemic inflammatory, exercise performance, as well as pulmonary hemodynamic and right heart function will be re-evaluation.
Detailed description
COPD patients will be disturbed by season 12 months follow up is better than 18 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD with OSA with CPAP treatment | – | Device: continuous positive airway pressureCOPD with OSA: CPAP treatment |
| COPD without OSA | – | –COPD without OSA, not treat with CPAP |
| COPD with OSA but without CPAP treatment | – | –COPD with OSA but patient refused CPAP treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- from outpatient clinic of CGMH and those in COPD cohort
Key inclusion criteria (4 listed)
- chronic stable COPD
- FEV1/FVC < 70%
- No response to beta-agonist
- without acute exacerbation within2 months
Key exclusion criteria (4 listed)
- Chronic respiratory failure (PaO2<60 mmHg, PaCO2>50 mmHg)
- Clinical evidence of congestive heart failure
- Facial defect and all the other condition that can't tolerate nasal mask
- Malignancy
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 |
|---|---|---|
| continuous positive airway pressureCPAP with adequate pressure for 1 day, 3 \& 12 months | Device | COPD with OSA with CPAP treatment |
Primary outcome
exercise performance
Time frame: 3 days, 3 & 12 months
the condition of COPD patient will be disturbed by season factor 12 months follow up will be better than 18 months
2 secondary outcomes
autonomic nerve activity
Time frame: 3 days, 3 & 12 months
mortality and acute exacerbation
Time frame: 1, 5, 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Derived from this study: PubMed 23782492Wang TY, Lo YL, Lee KY, Liu WT, Lin SM, Lin TY, Ni YL, Wang CY, Ho SC, Kuo HP. Nocturnal CPAP improves walking capacity in COPD patients with obstructive sleep apnoea. Respir Res. 2013 Jun 19;14(1):66. doi: 10.1186/1465-9921-14-66.
- Individual participant dataSharing planned: No
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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.
Yu-Lun Lo, MD study director
Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan
Tsai-Yu Wang, MD principal investigator
Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan
Han-Pin Kuo, MD,PHD study chair
Department of Thoracic Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD & OSA, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 4 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: finished, as of the sponsor's last update on 18 Jul 2018. 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 Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 performance (time frame: 3 days, 3 & 12 months). 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 NCT00914264, which also lists 1 linked publication.
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 18 Jul 2018.