Evaluation of Reactive Oxygen Metabolites in the Value of COPD

System Evaluation of Reactive Oxygen Metabolites in the Value of Chronic Obstructive Pulmonary Disease

This study through the long-term observation followed up for 2 years to find the change of the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the severity of COPD. Evaluate the differences of prognosis between the different oxidative stress level (according to the level of ROMs are divided into higher and normal phenotype). Explore the new oxidative stress evaluation index ROMs application value in COPD.

Study Overview

• Status: Unknown
• Conditions: COPD(Chronic Obstructive Pulmonary Disease)

Detailed Description

Reactive oxygen metabolites (reactive oxygen metabolites, ROMs) test is a method by measuring the total reactive oxygen metabolites (ROMs) content in blood so as to evaluate the overall level of oxidative stress in the human body .Our previous studies have established the method of detecting ROMs which is suitable for fully automatic biochemical analyser.Our study through the long-term observation followed up for 2 years to find the change of the COPD patients blood ROMs, systematically evaluate the relationship between ROMs and the severity of COPD. Evaluate the differences of prognosis between the different oxidative stress level (according to the level of ROMs are divided into higher and normal phenotype). Explore the new oxidative stress evaluation index ROMs application value in COPD.

• Study Type: Observational
• Enrollment (Anticipated): 320

Contacts and Locations

• Study Contact: Name: Jie Liu, Master; Phone Number: 18811225394; Email: chaoyangliujie@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Recruiting
      • Respiratory Institute;Beijing chaoyang hospital
      • Principal Investigator: Jie Liu
      • Contact: Jie Liu, Master; Phone Number: 18811225394; Email: chaoyangliujie@163.com
      • Principal Investigator: Xiaoning Bu, Doctor
      • Sub-Investigator: Hong Zhang, Master
      • Sub-Investigator: Xiaohong Chang
      • Sub-Investigator: Baomei Wu
      • Sub-Investigator: Jingyu Quan
      • Principal Investigator: Huimin Gong
      • Principal Investigator: Hongyan Pang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chaoyang hospital clinic

Description

Inclusion Criteria:

• Clinical diagnosis of COPD according to GOLD 2013

Exclusion Criteria:

• A history of asthma or other chronic lung diseases Take Antioxidant therapy There are new or recurrent symptomatic myocardial ischemia, severe arrhythmia, cardiac insufficiency cerebrovascular disease Senile dementia or cognitive impairment cancer Severe liver and kidney and other viscera function insufficiency Language communication barriers Limb activity disorder The last 3 months participated in sports training

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Stability in patients with COPD; Those patients diagnosed COPD according to the GOLD guideline and without acute exacerbation within one month.
AECOPD; the diagnosis of an exacerbation relies exclusively on the clinical presentation of the patient complaining of an acute change of symptoms (baseline dyspnea, cough, and/or sputum production) that is beyond normal day-to-day variation.
Healthy persons without smoking; The healthy people who do not smoke
Healthy persons with smoking; Healthy persons who smoke

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The different levels of the ROMs among different groups	Apply the analysis of variance to compare the different levels of ROMs among the four different groups	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The differences of the ROMs among the different lung function levels in the stable stage of COPD group	Apply the analysis of variance to compare the differences of the ROMs among the lung function levels in the stable stage of COPD group.	3 years
The relevance of the ROMs with the lung function levels in the stable stage of COPD group	Apply Pearson correlation to compare relevance the of the ROMs with the lung function levels in the stable stage of COPD group.	3 years
The relevance of the ROMs with the score of mMRC in the stable stage of COPD group	Apply Pearson correlation to compare relevance the of the ROMs with score of mMRC in the stable stage of COPD group.	3 years
The relevance of the ROMs with the score of CAT in the stable stage of COPD group	Apply Pearson correlation to compare relevance the of the ROMs with score of CAT in the stable stage of COPD group.	3 years
The relevance of the ROMs with the numbers of exacerbation in the stable stage of COPD group	Apply Pearson correlation to compare relevance the of the ROMs with numbers of exacerbation in the stable stage of COPD group.	3 years

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital
• Investigators: Study Director: Ting Yang, Doctor, Respiratory Institute, Beijing chaoyang hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (Estimate): November 21, 2014

Study Record Updates

• Last Update Posted (Estimate): November 21, 2014
• Last Update Submitted That Met QC Criteria: November 19, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: COPD; reactive oxygen metabolites
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: BJCYYT-12345