Role of Oxidative Stress in COPDNCT04748887
Oxidative Stress Markers in COPD
An observational study of Role of Oxidative Stress in COPD, run by Minia University at 1 site in Egypt.
Trial summary
Background:Striking feature of Chronic obstructive pulmonary disease (COPD) is its inability to resolve after cigarette smoke exposure has ended, which has contributed to the possibility that the disease could also be driven by other endogenous causes, such as autoimmunity or chronic infection . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Role of Oxidative Stress in COPD
- What is being tested?
- oxidative stess markers
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 1 Sep 2019
- How long will I take part?
- 4 Weeks
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Forty subjects of COPD who are non-smokers or stopped smoking for more than 6 months Based on the Global Initiative for Chronic Obstructive Lung Disease guidelines, COPD was diagnosed.9 2- Thirty subjects of non smokers healthy control
Who may be able to join
- 1-Forty subjects of COPD who are non-smokers or stopped smoking for more than 6 months Based on the Global Initiative for Chronic Obstructive Lung Disease guidelines, COPD was diagnosed.9 2- Thirty subjects of non smokers healthy control
Who cannot join
- Patients of:
- Acute exacerbation, at the time of the study, of COPD.
- Any obvious abnormal lung parenchymal lesions.
- Lung cancer.
- Congestive heart failure.
- current smokers
- Drugs e.g anti-inflammatory , steroids ,analgesics, insulin , antineoplastic, antipsychotic drugs in the previous 2 weeks before the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Minia University Hospital
Multiple Locations, Minya Governorate, 61691
About this study
Official title: Chronic Obstructive Pulmonary Disease in Non Smokers:Role of Oxidative Stress
Background:Striking feature of Chronic obstructive pulmonary disease (COPD) is its inability to resolve after cigarette smoke exposure has ended, which has contributed to the possibility that the disease could also be driven by other endogenous causes, such as autoimmunity or chronic infection . Many of the pathogenetic pathways involved in COPD and its development tend to be driven by oxidative stress.
- Conditions
- Role of Oxidative Stress in COPD
- Being tested
- oxidative stess markers
- Keywords
- COPD , oxidative stress, Superoxide Dismutase
- 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.
oxidative stess markersOther
Also called Superoxide Dismutase (SOD) and Malondialdehyde (MDA)
markers of oxidative stress , Superoxide Dismutase (SOD) and Malondialdehyde (MDA) by ( ELISA Kit SinoGeneClon Biotech Co.,Ltd Catalog No : SG- 10188) .
| Study group | Role | What they receive |
|---|---|---|
| nonsmokers copd cases , | Fourty subjects of COPD who are non-smokers or stopped smoking for more than 6 months Receives: Other: oxidative stess markers | |
| non smokers healthy control | Thirty subjects of non smokers healthy control Receives: Other: oxidative stess markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxidative stress markers in non smokers COPD compared to healthy control
markers of oxidative stress , Superoxide Dismutase (SOD) and Malondialdehyde (MDA) by ( ELISA Kit SinoGeneClon Biotech Co.,Ltd Catalog No : SG- 10188) .
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Sep 2018
- Primary completion1 Apr 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Role of Oxidative Stress in COPDStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 70 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zainab hassan saeed, Minia University
- Investigators
- zainab H Saeed, MD, Principal investigator, MD chest diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748887
- Sponsor's protocol ID
- oxidative stress
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Obstructive Pulmonary Disease in Non Smokers:Role of Oxidative Stress
- ClinicalTrials.gov ID
- NCT04748887
- Acronym / sponsor ID
- oxidative stress
- Conditions
- Role of Oxidative Stress in COPD
- Keywords
- COPD , oxidative stress, Superoxide Dismutase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 10 Feb 2021 (actual)
- 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.
Background:Striking feature of Chronic obstructive pulmonary disease (COPD) is its inability to resolve after cigarette smoke exposure has ended, which has contributed to the possibility that the disease could also be driven by other endogenous causes, such as autoimmunity or chronic infection . Many of the pathogenetic pathways involved in COPD and its development tend to be driven by oxidative stress.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nonsmokers copd cases , | – | Other: oxidative stess markersFourty subjects of COPD who are non-smokers or stopped smoking for more than 6 months |
| non smokers healthy control | – | Other: oxidative stess markersThirty subjects of non smokers healthy control |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Forty subjects of COPD who are non-smokers or stopped smoking for more than 6 months Based on the Global Initiative for Chronic Obstructive Lung Disease guidelines, COPD was diagnosed.9 2- Thirty subjects of non smokers healthy control
Key inclusion criteria (1 listed)
- 1-Forty subjects of COPD who are non-smokers or stopped smoking for more than 6 months Based on the Global Initiative for Chronic Obstructive Lung Disease guidelines, COPD was diagnosed.9 2- Thirty subjects of non smokers healthy control
Key exclusion criteria (7 listed)
- Patients of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxidative stess markersAlso: Superoxide Dismutase (SOD) and Malondialdehyde (MDA)markers of oxidative stress , Superoxide Dismutase (SOD) and Malondialdehyde (MDA) by ( ELISA Kit SinoGeneClon Biotech Co.,Ltd Catalog No : SG- 10188) . | Other | non smokers healthy control, nonsmokers copd cases , |
Primary outcome
oxidative stress markers in non smokers COPD compared to healthy control
Time frame: 1month
markers of oxidative stress , Superoxide Dismutase (SOD) and Malondialdehyde (MDA) by ( ELISA Kit SinoGeneClon Biotech Co.,Ltd Catalog No : SG- 10188) .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No
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.
zainab H Saeed, MD principal investigator
MD chest diseases
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 Role of Oxidative Stress in COPD, run by Minia University at 1 site in Egypt.
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 7 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: finished, as of the sponsor's last update on 10 Feb 2021. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxidative stress markers in non smokers COPD compared to healthy control (time frame: 1month). 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 10 Feb 2021.