COPD Clinical Trial
Official title:
Studies in Pulmonary Inflammation and the Effectiveness of Pulmonary Recovery in COPD Patients:the Mechanism of Proteoglycan 4
Verified date | May 2016 |
Source | Taipei Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Ministry of Health and Welfare |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 90 |
Est. completion date | February 2019 |
Est. primary completion date | February 2019 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Hospitalized patients with acute exacerbation of COPD 1. 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%. 2. Age ? 40 and ? 80 years old, is currently not accepting any research project. 3. Physician assess the patient is currently in stable condition vital signs, complain dyspnea of exercise, consult RT for pulmonary rehabilitation. 4. The purpose of this study by researchers explain, the researchers agreed to participate in this. Stable COPD outpatients 1. 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%. 2. Age ? 40 and ? 80 years old, is currently not accepting any research project. 3. The purpose of this study by researchers explain, the researchers agreed to participate in this. Exclusion Criteria: - Hospitalized patients with acute exacerbation of COPD 1. Unstable vital signs: blood pressure <90 mm Hg, blood oxygen levels (SpO2) at Tx under still <85%. 2. Associated with neuromuscular function disorders such as hemiplegia or no independent walking function. 3. Have been diagnosed with severe mental disorders, such as dementia or or unable to cooperating people. Stable COPD outpatients 1. Over the past three months there have been acute infection or are in a state of acute attacks. 2. Associated with neuromuscular function disorders such as hemiplegia or no independent walking function. 3. Have been diagnosed with severe mental disorders, such as dementia or unable to cooperating people |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Taipei Medical University |
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;14:22. doi: 10.1186/1465-9921-14-22. — View Citation
Lee 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. — View Citation
Wang 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The systemic inflamation biomakers | Measured the proteaglycan4?IL-6?IL-8?TNFa?CRP& IL-10 from the supernatant with COPD patients | 0~12 months | Yes |
Secondary | Exercise capacity | Six-minute walking distance and lung | 0~12 months | Yes |
Secondary | 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 | 0~12 months | Yes |
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