COPD(Chronic Obstructive Pulmonary Disease)NCT02297633
Evaluation of Reactive Oxygen Metabolites in the Value of COPD
An observational study of COPD(Chronic Obstructive Pulmonary Disease), run by Beijing Chao Yang Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD(Chronic Obstructive Pulmonary Disease)
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chaoyang hospital clinic
Who may be able to join
- Clinical diagnosis of COPD according to GOLD 2013
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Respiratory Institute;Beijing chaoyang hospital
Beijing, Beijing Municipality, 100020
Ting Yang, Doctor, 13651380809, dryangting@qq.com
Jie Liu, Master, 18811225394, chaoyangliujie@163.com
About this study
Official title: 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.
Read the 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.
- Keywords
- COPD, reactive oxygen metabolites
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD(Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie liu, Beijing Chao Yang Hospital
- Investigators
- Ting Yang, Doctor, Study director, Respiratory Institute, Beijing chaoyang hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297633
- Sponsor's protocol ID
- BJCYYT-12345
- Status last verified
- Nov 2014
- First submitted
- 17 Nov 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- System Evaluation of Reactive Oxygen Metabolites in the Value of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02297633
- Acronym / sponsor ID
- BJCYYT-12345
- Keywords
- COPD, reactive oxygen metabolites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 21 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chaoyang hospital clinic
Key inclusion criteria (1 listed)
- Clinical diagnosis of COPD according to GOLD 2013
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The different levels of the ROMs among different groups
Time frame: 3 years
Apply the analysis of variance to compare the different levels of ROMs among the four different groups
5 secondary outcomes
The differences of the ROMs among the different lung function levels in the stable stage of COPD group
Time frame: 3 years
The relevance of the ROMs with the lung function levels in the stable stage of COPD group
Time frame: 3 years
The relevance of the ROMs with the score of mMRC in the stable stage of COPD group
Time frame: 3 years
The relevance of the ROMs with the score of CAT in the stable stage of COPD group
Time frame: 3 years
The relevance of the ROMs with the numbers of exacerbation in the stable stage of COPD group
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Yang, Doctor study director
Respiratory Institute, Beijing chaoyang hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD(Chronic Obstructive Pulmonary Disease), run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Yang, Doctor (13651380809, dryangting@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The different levels of the ROMs among different groups (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.