Evaluation of Reactive Oxygen Metabolites in the Value of COPD

• Conditions: COPD(Chronic Obstructive Pulmonary Disease)

• Registration Number: NCT02297633
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2014-10
• Status Verified: 2014-11
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-19
• Last Update Submitted: 2014-11-19
• Study First Posted: 2014-11-21
• Last Update Posted: 2014-11-21
• Primary Completion: 2017-05
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The different levels of the ROMs among different groups	3 years	Apply the analysis of variance to compare the different levels of ROMs among the four different groups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Respiratory Institute;Beijing chaoyang hospital; 🇨🇳 Beijing, Beijing, China