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Clinical Trials/NCT02764658
NCT02764658UnknownNot Applicable

Studies in Pulmonary Inflammation and the Effectiveness of Pulmonary Recovery in COPD Patients:the Mechanism of Proteoglycan 4

Taipei Medical University0 sites90 target enrollmentStarted: May 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
90
Primary Endpoint
The systemic inflamation biomakers

Study Overview

Brief 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. 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.

  1. 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. 2. 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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
40 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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
  • •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.

Exclusion Criteria

  • •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

Arms & Interventions

Pulmonary recovery on the AECOPD

Experimental

Study in the pulmonary inflammation and the effectiveness of pulmonary recovery in AECOPD Patients

Intervention: Pulmonary recovery on the AECOPD (Device)

Pulmonary recovery on the AECOPD

Experimental

Study in the pulmonary inflammation and the effectiveness of pulmonary recovery in AECOPD Patients

Intervention: Routine care on the AECOPD (Other)

Pulmonary recovery on the AECOPD

Experimental

Study in the pulmonary inflammation and the effectiveness of pulmonary recovery in AECOPD Patients

Intervention: Routine care on the stable COPD (Other)

Routine care on the AECOPD

Other

Study in the pulmonary inflammation and the effectiveness of pulmonary recovery in AECOPD Patients

Intervention: Routine care on the AECOPD (Other)

Routine care on the AECOPD

Other

Study in the pulmonary inflammation and the effectiveness of pulmonary recovery in AECOPD Patients

Intervention: Routine care on the stable COPD (Other)

Routine care on the stable COPD

Other

Study in the pulmonary inflammation and the effectiveness of pulmonary recovery in stabel COPD Patients

Intervention: Routine care on the stable COPD (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Exercise capacity(0~12 months)
  • The correlaton with the exercise capacity and systemic inflammationcytokines(0~12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shu-Chuan Ho

School of Respiratory Therapy

Taipei Medical University

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