COPDNCT02764658
Proteoglycan 4 Mechanism the Effectiveness of Pulmaonry Recovery in COPD Patients
A study testing Pulmonary recovery on the AECOPD, Routine care on the AECOPD and Routine care on the stable COPD in people with COPD, run by Taipei Medical University.
Trial summary
The investigators previous research has demonstrated that proteoglycan 4 (PRG4) may be a biomarker for identification of severity in COPD. PRG4 was more sensitive and specific than CRP for confirming COPD severity and acute exacerbation frequency. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- Pulmonary recovery on the AECOPD, Routine care on the AECOPD and Routine care on the stable COPD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Feb 2019
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients with acute exacerbation of COPD
- GOLD diagnostic criteria based on the COPD, the use of inhaled bronchodilators: the first second forced expiratory volume (FEV1.0) / forced vital capacity (FVC) <70%.
- Age ≧ 40 and ≦ 80 years old, is currently not accepting any research project.
- Physician assess the patient is currently in stable condition vital signs, complain dyspnea of exercise, consult RT for pulmonary rehabilitation.
- The purpose of this study by researchers explain, the researchers agreed to participate in this.
- Stable COPD outpatients
Show all 9Show fewer
- GOLD diagnostic criteria based on the COPD, the use of inhaled bronchodilators: the first second forced expiratory volume (FEV1.0) / forced vital capacity (FVC) <70%.
- Age ≧ 40 and ≦ 80 years old, is currently not accepting any research project.
- The purpose of this study by researchers explain, the researchers agreed to participate in this.
Who cannot join
- Hospitalized patients with acute exacerbation of COPD
- Unstable vital signs: blood pressure <90 mm Hg, blood oxygen levels (SpO2) at Tx under still <85%.
- Associated with neuromuscular function disorders such as hemiplegia or no independent walking function.
- Have been diagnosed with severe mental disorders, such as dementia or or unable to cooperating people.
- Stable COPD outpatients
- Over the past three months there have been acute infection or are in a state of acute attacks.
- Associated with neuromuscular function disorders such as hemiplegia or no independent walking function.
- Have been diagnosed with severe mental disorders, such as dementia or unable to cooperating people
About this study
Official title: Studies in Pulmonary Inflammation and the Effectiveness of Pulmonary Recovery in COPD Patients：the Mechanism of Proteoglycan 4
The investigators previous research has demonstrated that proteoglycan 4 (PRG4) may be a biomarker for identification of severity in COPD. PRG4 was more sensitive and specific than CRP for confirming COPD severity and acute exacerbation frequency. It was related to the 1-year force vital capacity decline in COPD patients. The past study found that Prg4 is an immunomodulatory factor regulating parathyroid hormone actions on hematopoietic cells in mice. Previous report showed that voluntary wheel running and fluid flow shear stress that promote the expression of the Prg4 and association with pulmonary inflammation. COPD patients are characterized by a progressive decrease of lung function that is associated with increased in the airway and systemic inflammation. Pulmonary recovery (PR) is able to decrease acute exacerbation, maintain pulmonary function, increase exercise tolerance and improve quality of life in COPD patients, but it is unknown the mechanism of PRG4. The current study aimed to study in the pulmonary inflammation and the effectiveness of pulmonary recovery in COPD Patients：The mechanism of PRG 4.
Read the detailed description
The investigators previous research has demonstrated that proteoglycan 4 (PRG4) may be a biomarker for identification of severity in COPD. PRG4 was more sensitive and specific than CRP for confirming COPD severity and acute exacerbation frequency. It was related to the 1-year force vital capacity decline in COPD patients. The past study found that Prg4 is an immunomodulatory factor regulating parathyroid hormone actions on hematopoietic cells in mice. Previous report showed that voluntary wheel running and fluid flow shear stress that promote the expression of the Prg4 and association with pulmonary inflammation. COPD patients are characterized by a progressive decrease of lung function that is associated with increased in the airway and systemic inflammation. Pulmonary recovery (PR) is able to decrease acute exacerbation, maintain pulmonary function, increase exercise tolerance and improve quality of life in COPD patients, but it is unknown the mechanism of PRG4. The current study aimed to study in the pulmonary inflammation and the effectiveness of pulmonary recovery in COPD Patients：The mechanism of PRG 4.
- Proteoglycan 4 is correlated with pulmonary inflammation and decline of pulmonary function in the different phenotype of COPD. 1-1 Classification of characteristic、the severity of disease、pulmonary functional test、exercise capacity and blood sample collection for routine analysis. 1-2 Human blood bio-bank and molecular analysis: PRG4、IL-6、IL-8、TNFα、CRP\& IL-10. 1-3 To investigate whether daily physical activity、hypoxia and hyperinflation were associated with airway inflammation and PRG4 in COPD patients.
- The mechanism of PRG 4 in the effectiveness of PR on the AECOPD. 2-1 The PR program: The combination effect of negative pressure ventilation and exercise training program on acute exacerbation of COPD (AECOPD). 2-2 To examine the efficacy of PR on cytokines and PRG4 protein. 2-3 Correlation between PR effects and PRG4：PR is correlation with PRG4、clinical progression、exercise tolerance、PFT change and SpO2 during exercise.
- In vitro cell culture research models 3-1 Pulmonary inflammatory model establishment：Human primary epithelium cell culture and Beas-2B for IL-1β、TNFα、LPS、IL-10 and H2O2 effects. 3-2 Purification of peripheral blood monocyte cells：Primary culture to evaluate pulmonary inflammation and treatment effects. 3-3 Hypoxia experiments：To test whether hypoxia induces regulation of PRG4 protein or different cytokines in epithelial cells. 3-4 Inhibit PRG4：To prove the mechanism of PRG4 under the hypoxia model by PRG4 siRNA。
- In vivo animal research models 4-1 Smoke-COPD mice models establishment： 4-2 To determinate the effects of exercise training in COPD mine. 4-3 To investigate on PRG4 protein in pulmonary inflammation and the effectiveness of exercise training in the tissue and serum of mice.
- Conditions
- COPD
- Being tested
- Pulmonary recovery on the AECOPD, Routine care on the AECOPD, Routine care on the stable COPD
- 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.
Pulmonary recovery on the AECOPDDevice
Also called Ergometer for limb muscle training, Negative pressure ventilator, Fibit monitor
The combination effect of negative pressure ventilation, limb muscle exercise training program and fibit monitor on acute exacerbation of AECOPD. To investigate the daily physical activity in routine care patients with after AECOPD and stable stage.
Routine care on the AECOPDOther
Also called Physical daily activity, Fibit monitor
To investigate whether daily physical activity、hypoxia and hyperinflation were associated with airway inflammation and PRG4 in Routine care patients wtih AECOPD and stable stage.
Routine care on the stable COPDOther
Also called Physical daily activity, Fibit monitor
To investigate whether daily physical activity、hypoxia and hyperinflation were associated with airway inflammation and PRG4 in Non-Pulmanary recovery patients wtih stable COPD.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary recovery on the AECOPD | Experimental | Study in the pulmonary inflammation and the effectiveness of pulmonary recovery in AECOPD Patients Receives: Device: Pulmonary recovery on the AECOPD; Other: Routine care on the AECOPD; Other: Routine care on the stable COPD |
| Routine care on the AECOPD | Other | Study in the pulmonary inflammation and the effectiveness of pulmonary recovery in AECOPD Patients Receives: Other: Routine care on the AECOPD; Other: Routine care on the stable COPD |
| Routine care on the stable COPD | Other | Study in the pulmonary inflammation and the effectiveness of pulmonary recovery in stabel COPD Patients Receives: Other: Routine care on the stable COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The systemic inflamation biomakers
Measured the proteaglycan4、IL-6、IL-8、TNFα、CRP\& IL-10 from the supernatant with COPD patients
Measured: 0~12 months
Secondary outcomes (2)
Exercise capacity
Six-minute walking distance and lung
Measured: 0~12 months
The correlaton with the exercise capacity and systemic inflammationcytokines
volumePulmonary recovery is correlation with PRG4、clinical progression、exercise tolerance、PFT change and SpO2 during exercise
Measured: 0~12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMay 2016
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Chuan Ho, Taipei Medical University
- Investigators
- Shu-Chuan Ho, Principal investigator, School of Respiratory Therapy, College of Medicine, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764658
- Sponsor's protocol ID
- TMU-JIRB Ho1.2/20160212
- Status last verified
- May 2016
- First submitted
- 1 May 2016
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ho SC, Lin HC, Kuo HP, Chen LF, Sheng TF, Jao WC, Wang CH, Lee KY. Exercise training with negative pressure ventilation improves exercise capacity in patients with severe restrictive lung disease: a prospective controlled study. Respir Res. 2013 Feb 19;14(1):22. doi: 10.1186/1465-9921-14-22.
PubMed 23421438Lee KY, Chuang HC, Chen TT, Liu WT, Su CL, Feng PH, Chiang LL, Bien MY, Ho SC. Proteoglycan 4 is a diagnostic biomarker for COPD. Int J Chron Obstruct Pulmon Dis. 2015 Sep 18;10:1999-2007. doi: 10.2147/COPD.S90926. eCollection 2015.
PubMed 26451097Wang CH, Chou PC, Joa WC, Chen LF, Sheng TF, Ho SC, Lin HC, Huang CD, Chung FT, Chung KF, Kuo HP. Mobile-phone-based home exercise training program decreases systemic inflammation in COPD: a pilot study. BMC Pulm Med. 2014 Aug 30;14:142. doi: 10.1186/1471-2466-14-142.
PubMed 25175787
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies in Pulmonary Inflammation and the Effectiveness of Pulmonary Recovery in COPD Patients：the Mechanism of Proteoglycan 4
- ClinicalTrials.gov ID
- NCT02764658
- Acronym / sponsor ID
- TMU-JIRB Ho1.2/20160212
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 6 May 2016 (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 investigators previous research has demonstrated that proteoglycan 4 (PRG4) may be a biomarker for identification of severity in COPD. PRG4 was more sensitive and specific than CRP for confirming COPD severity and acute exacerbation frequency. It was related to the 1-year force vital capacity decline in COPD patients. The past study found that Prg4 is an immunomodulatory factor regulating parathyroid hormone actions on hematopoietic cells in mice. Previous report showed that voluntary wheel running and fluid flow shear stress that promote the expression of the Prg4 and association with pulmonary inflammation. COPD patients are characterized by a progressive decrease of lung function that is associated with increased in the airway and systemic inflammation. Pulmonary recovery (PR) is able to decrease acute exacerbation, maintain pulmonary function, increase exercise tolerance and improve quality of life in COPD patients, but it is unknown the mechanism of PRG4. The current study aimed to study in the pulmonary inflammation and the effectiveness of pulmonary recovery in COPD Patients：The mechanism of PRG 4.
Detailed description
The investigators previous research has demonstrated that proteoglycan 4 (PRG4) may be a biomarker for identification of severity in COPD. PRG4 was more sensitive and specific than CRP for confirming COPD severity and acute exacerbation frequency. It was related to the 1-year force vital capacity decline in COPD patients. The past study found that Prg4 is an immunomodulatory factor regulating parathyroid hormone actions on hematopoietic cells in mice. Previous report showed that voluntary wheel running and fluid flow shear stress that promote the expression of the Prg4 and association with pulmonary inflammation. COPD patients are characterized by a progressive decrease of lung function that is associated with increased in the airway and systemic inflammation. Pulmonary recovery (PR) is able to decrease acute exacerbation, maintain pulmonary function, increase exercise tolerance and improve quality of life in COPD patients, but it is unknown the mechanism of PRG4. The current study aimed to study in the pulmonary inflammation and the effectiveness of pulmonary recovery in COPD Patients：The mechanism of PRG 4.
- Proteoglycan 4 is correlated with pulmonary inflammation and decline of pulmonary function in the different phenotype of COPD. 1-1 Classification of characteristic、the severity of disease、pulmonary functional test、exercise capacity and blood sample collection for routine analysis. 1-2 Human blood bio-bank and molecular analysis: PRG4、IL-6、IL-8、TNFα、CRP\& IL-10. 1-3 To investigate whether daily physical activity、hypoxia and hyperinflation were associated with airway inflammation and PRG4 in COPD patients.
- The mechanism of PRG 4 in the effectiveness of PR on the AECOPD. 2-1 The PR program: The combination effect of negative pressure ventilation and exercise training program on acute exacerbation of COPD (AECOPD). 2-2 To examine the efficacy of PR on cytokines and PRG4 protein. 2-3 Correlation between PR effects and PRG4：PR is correlation with PRG4、clinical progression、exercise tolerance、PFT change and SpO2 during exercise.
- In vitro cell culture research models 3-1 Pulmonary inflammatory model establishment：Human primary epithelium cell culture and Beas-2B for IL-1β、TNFα、LPS、IL-10 and H2O2 effects. 3-2 Purification of peripheral blood monocyte cells：Primary culture to evaluate pulmonary inflammation and treatment effects. 3-3 Hypoxia experiments：To test whether hypoxia induces regulation of PRG4 protein or different cytokines in epithelial cells. 3-4 Inhibit PRG4：To prove the mechanism of PRG4 under the hypoxia model by PRG4 siRNA。
- In vivo animal research models 4-1 Smoke-COPD mice models establishment： 4-2 To determinate the effects of exercise training in COPD mine. 4-3 To investigate on PRG4 protein in pulmonary inflammation and the effectiveness of exercise training in the tissue and serum of mice.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulmonary recovery on the AECOPD | Experimental | Device: Pulmonary recovery on the AECOPD, Other: Routine care on the AECOPD, Other: Routine care on the stable COPDStudy in the pulmonary inflammation and the effectiveness of pulmonary recovery in AECOPD Patients |
| Routine care on the AECOPD | Other | Other: Routine care on the AECOPD, Other: Routine care on the stable COPDStudy in the pulmonary inflammation and the effectiveness of pulmonary recovery in AECOPD Patients |
| Routine care on the stable COPD | Other | Other: Routine care on the stable COPDStudy in the pulmonary inflammation and the effectiveness of pulmonary recovery in stabel COPD Patients |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Hospitalized patients with acute exacerbation of COPD
- Stable COPD outpatients
- GOLD diagnostic criteria based on the COPD, the use of inhaled bronchodilators: the first second forced expiratory volume (FEV1.0) / forced vital capacity (FVC) <70%.
- Age ≧ 40 and ≦ 80 years old, is currently not accepting any research project.
- The purpose of this study by researchers explain, the researchers agreed to participate in this.
Key exclusion criteria (8 listed)
- Hospitalized patients with acute exacerbation of COPD
- Stable COPD outpatients
- Over the past three months there have been acute infection or are in a state of acute attacks.
- Associated with neuromuscular function disorders such as hemiplegia or no independent walking function.
- Have been diagnosed with severe mental disorders, such as dementia or unable to cooperating people
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 |
|---|---|---|
| Pulmonary recovery on the AECOPDAlso: Ergometer for limb muscle training, Negative pressure ventilator, Fibit monitorThe combination effect of negative pressure ventilation, limb muscle exercise training program and fibit monitor on acute exacerbation of AECOPD. To investigate the daily physical activity in routine care patients with after AECOPD and stable stage. | Device | Pulmonary recovery on the AECOPD |
| Routine care on the AECOPDAlso: Physical daily activity, Fibit monitorTo investigate whether daily physical activity、hypoxia and hyperinflation were associated with airway inflammation and PRG4 in Routine care patients wtih AECOPD and stable stage. | Other | Pulmonary recovery on the AECOPD, Routine care on the AECOPD |
| Routine care on the stable COPDAlso: Physical daily activity, Fibit monitorTo investigate whether daily physical activity、hypoxia and hyperinflation were associated with airway inflammation and PRG4 in Non-Pulmanary recovery patients wtih stable COPD. | Other | Pulmonary recovery on the AECOPD, Routine care on the AECOPD, Routine care on the stable COPD |
Primary outcome
The systemic inflamation biomakers
Time frame: 0~12 months
Measured the proteaglycan4、IL-6、IL-8、TNFα、CRP\& IL-10 from the supernatant with COPD patients
2 secondary outcomes
Exercise capacity
Time frame: 0~12 months
The correlaton with the exercise capacity and systemic inflammationcytokines
Time frame: 0~12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Background: PubMed 23421438Ho SC, Lin HC, Kuo HP, Chen LF, Sheng TF, Jao WC, Wang CH, Lee KY. Exercise training with negative pressure ventilation improves exercise capacity in patients with severe restrictive lung disease: a prospective controlled study. Respir Res. 2013 Feb 19;14(1):22. doi: 10.1186/1465-9921-14-22.
- Background: PubMed 26451097Lee KY, Chuang HC, Chen TT, Liu WT, Su CL, Feng PH, Chiang LL, Bien MY, Ho SC. Proteoglycan 4 is a diagnostic biomarker for COPD. Int J Chron Obstruct Pulmon Dis. 2015 Sep 18;10:1999-2007. doi: 10.2147/COPD.S90926. eCollection 2015.
- Background: PubMed 25175787Wang CH, Chou PC, Joa WC, Chen LF, Sheng TF, Ho SC, Lin HC, Huang CD, Chung FT, Chung KF, Kuo HP. Mobile-phone-based home exercise training program decreases systemic inflammation in COPD: a pilot study. BMC Pulm Med. 2014 Aug 30;14:142. doi: 10.1186/1471-2466-14-142.
- Individual participant dataSharing planned: No
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
Shu-Chuan Ho principal investigator
School of Respiratory Therapy, College of Medicine, Taipei Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary recovery on the AECOPD, Routine care on the AECOPD and Routine care on the stable COPD in people with COPD, run by Taipei Medical University.
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 9 inclusion and 8 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 9 May 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?
The systemic inflamation biomakers (time frame: 0~12 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 NCT02764658, which also lists 3 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 9 May 2016.