Evaluation of Reactive Oxygen Metabolites in the Value of COPD

COPD(Chronic Obstructive Pulmonary Disease) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02297633
• Other study ID #: BJCYYT-12345
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2014
• Last updated: November 19, 2014
• Start date: October 2014
• Est. completion date: July 2017

Study information

• Verified date: November 2014
• Source: Beijing Chao Yang Hospital
• Contact: Ting Yang, Doctor
• Phone: 13651380809
• Email: dryangting[@]qq.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD(Chronic Obstructive Pulmonary Disease)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
China	Respiratory Institute;Beijing chaoyang hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes