Chronic Obstructive Pulmonary DiseaseNCT06503315
Genetic Polymorphism in Matrix Metalloproteinase 9 in Chronic Obstructive Pulmonary Disease in Sohag University Hospital.
An observational study of Chronic Obstructive Pulmonary Disease, run by Sohag University at 1 site in Egypt.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a heterogeneous and complex disease with multiple clinical presentations or phenotypes and remains a highly prevalent condition, causing significant morbidity and mortality worldwide. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Oct 2024to 24 Feb 2026
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: chronic respiratory symptom and signs such as cough ,breathlessness , wheeze ; forced expiratory volume in one second(FEV1)of predicted (FEV1%) less than 80 % ; the ratio of FEV1 to forced vital capacity (FVC , FEV1/ FVC)<70 % ; FEV1reversibility after inhalation of 200g salbutamol (bronchodilator) of less than 12 % of prebronchodilator FEV1.
Who may be able to join
- chronic respiratory symptom and signs such as cough ,breathlessness , wheeze ; forced expiratory volume in one second(FEV1)of predicted (FEV1%) less than 80 % ; the ratio of FEV1 to forced vital capacity (FVC , FEV1/ FVC)<70 % ; FEV1reversibility after inhalation of 200g salbutamol (bronchodilator) of less than 12 % of prebronchodilator FEV1.
Who cannot join
- Coexistence of asthma and COPD or with earlier history of bronchial asthma as well as patients who have never smoked were excluded from the study.
- -
Trial locations and contacts
1 site in 1 country.
Nagwa S Ahmed, professor contact
About this study
Chronic obstructive pulmonary disease (COPD) is a heterogeneous and complex disease with multiple clinical presentations or phenotypes and remains a highly prevalent condition, causing significant morbidity and mortality worldwide.
Chronic obstructive pulmonary disease (COPD) is the third most common cause of global mortality, affecting over 210 million individuals.
Read more
Chronic obstructive pulmonary disease (COPD) is a chronic airway disease involving chronic local and systemic inflammatory changes, clinically characterized by continuous and progressive airflow obstruction with airway remodeling and lung parenchyma destruction as pathological basis.
The precise molecular mechanism underlying the pathogenesis of COPD remains unclear ( Zhang J. et al., 2021). At present, it is generally believed that several risk factors are directly related to the pathogenesis of COPD, including host and environmental factors .
Among environmental factors, smoking, exposure to chemicals, indoor and outdoor air pollution are risk factors for COPD.
Host factors of COPD include antitrypsin-1, excessive deposition of extracellular matrix (ECM), corticosteroids, inflammatory stimuli, and metabolic imbalances .
Matrix metalloproteinases (MMPs) is a family of calcium- and zinc-dependent proteinase. There are currently at least 26 subtypes that can degrade almost all extracellular matrix and basement membrane components .
The MMP-9 gene is located on human chromosome 16, including 13 exons and 12 introns and its regulation mainly occurs at the transcriptional level. In the pathogenesis of COPD, MMP-9 mainly degrades the extracellular matrix and basement membrane of alveolar wall, destroying the normal structure of lung tissue. At the same time, MMP-9 also repairs the extracellular matrix and participates in respiratory tract reconstruction.
In addition, MMP-9 can also participate in inflammatory response, causing inflammatory cells to accumulate in the airway, thus increasing airway responsiveness. Study found that MMP-9 is highly expressed in the lung tissues of COPD patients and leads to generation of sputum. MMPs are important in COPD. They degrade matrix proteins (elastin, collagen) during the disease progression .
Therefore the analysis of MMP-9 gene polymorphism is an important starting point to explore the susceptibility to COPD. It has been found that there is a mutation from C to T at site 1562 of promoter MMP-9, which may affect the expression level of MMP-9 gene. The MMP-9-C1562T polymorphism is an important reason for the abnormal increase of MMP-9 expression level .
- Conditions
- Chronic Obstructive Pulmonary Disease
- 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 |
|---|---|---|
| cases group | Clinical assessment is based on the presence of symptoms (low vs. high) and the previous history of exacerbation( ECOPD) (≤ 1 moderate ECOPD in the previous year vs. more than one severe (hospitalized) ECOPD). Using these two dimensions, GOLD 2023 proposes to classify COPD patients in one of three groups (A, B, or E) . | |
| control group | The control group includes 70 asymptomatic smokers and will be matched with cases by sex, age, smoking status, lacking chronic diseases in the respiratory system as malignancy and bronchial asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matrix metalloproteinase-9 gene polymorphism
Matrix metalloproteinase-9 gene polymorphism by conventional PCR
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion24 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yassmin Ismail, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503315
- Sponsor's protocol ID
- Soh-Med-24-06-09MS
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Agusti A, Bohm M, Celli B, Criner GJ, Garcia-Alvarez A, Martinez F, Sin DD, Vogelmeier CF. GOLD COPD DOCUMENT 2023: a brief update for practicing cardiologists. Clin Res Cardiol. 2024 Feb;113(2):195-204. doi: 10.1007/s00392-023-02217-0. Epub 2023 May 26.
PubMed 37233751Cabral-Pacheco GA, Garza-Veloz I, Castruita-De la Rosa C, Ramirez-Acuna JM, Perez-Romero BA, Guerrero-Rodriguez JF, Martinez-Avila N, Martinez-Fierro ML. The Roles of Matrix Metalloproteinases and Their Inhibitors in Human Diseases. Int J Mol Sci. 2020 Dec 20;21(24):9739. doi: 10.3390/ijms21249739.
PubMed 33419373Cai L, Zuo X, Ma L, Zhang Y, Xu F, Lu B. Associations of MMP9 polymorphism with the risk of severe pneumonia in a Southern Chinese children population. BMC Infect Dis. 2024 Jan 2;24(1):19. doi: 10.1186/s12879-023-08931-4.
PubMed 38166679Lu Z, Coll P, Maitre B, Epaud R, Lanone S. Air pollution as an early determinant of COPD. Eur Respir Rev. 2022 Aug 10;31(165):220059. doi: 10.1183/16000617.0059-2022. Print 2022 Sep 30.
PubMed 35948393
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphism in Matrix Metalloproteinase 9 in Chronic Obstructive Pulmonary Disease in Sohag University Hospital.
- ClinicalTrials.gov ID
- NCT06503315
- Acronym / sponsor ID
- Soh-Med-24-06-09MS
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 24 Feb 2026 (estimated)
- First posted
- 16 Jul 2024 (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.
Chronic obstructive pulmonary disease (COPD) is a heterogeneous and complex disease with multiple clinical presentations or phenotypes and remains a highly prevalent condition, causing significant morbidity and mortality worldwide.
Chronic obstructive pulmonary disease (COPD) is the third most common cause of global mortality, affecting over 210 million individuals.
Chronic obstructive pulmonary disease (COPD) is a chronic airway disease involving chronic local and systemic inflammatory changes, clinically characterized by continuous and progressive airflow obstruction with airway remodeling and lung parenchyma destruction as pathological basis.
The precise molecular mechanism underlying the pathogenesis of COPD remains unclear ( Zhang J. et al., 2021). At present, it is generally believed that several risk factors are directly related to the pathogenesis of COPD, including host and environmental factors .
Among environmental factors, smoking, exposure to chemicals, indoor and outdoor air pollution are risk factors for COPD.
Host factors of COPD include antitrypsin-1, excessive deposition of extracellular matrix (ECM), corticosteroids, inflammatory stimuli, and metabolic imbalances .
Matrix metalloproteinases (MMPs) is a family of calcium- and zinc-dependent proteinase. There are currently at least 26 subtypes that can degrade almost all extracellular matrix and basement membrane components .
The MMP-9 gene is located on human chromosome 16, including 13 exons and 12 introns and its regulation mainly occurs at the transcriptional level. In the pathogenesis of COPD, MMP-9 mainly degrades the extracellular matrix and basement membrane of alveolar wall, destroying the normal structure of lung tissue. At the same time, MMP-9 also repairs the extracellular matrix and participates in respiratory tract reconstruction.
In addition, MMP-9 can also participate in inflammatory response, causing inflammatory cells to accumulate in the airway, thus increasing airway responsiveness. Study found that MMP-9 is highly expressed in the lung tissues of COPD patients and leads to generation of sputum. MMPs are important in COPD. They degrade matrix proteins (elastin, collagen) during the disease progression .
Therefore the analysis of MMP-9 gene polymorphism is an important starting point to explore the susceptibility to COPD. It has been found that there is a mutation from C to T at site 1562 of promoter MMP-9, which may affect the expression level of MMP-9 gene. The MMP-9-C1562T polymorphism is an important reason for the abnormal increase of MMP-9 expression level .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases group | – | –Clinical assessment is based on the presence of symptoms (low vs. high) and the previous history of exacerbation( ECOPD) (≤ 1 moderate ECOPD in the previous year vs. more than one severe (hospitalized) ECOPD). Using these two dimensions, GOLD 2023 proposes to classify COPD patients in one of three groups (A, B, or E) . |
| control group | – | –The control group includes 70 asymptomatic smokers and will be matched with cases by sex, age, smoking status, lacking chronic diseases in the respiratory system as malignancy and bronchial asthma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- chronic respiratory symptom and signs such as cough ,breathlessness , wheeze ; forced expiratory volume in one second(FEV1)of predicted (FEV1%) less than 80 % ; the ratio of FEV1 to forced vital capacity (FVC , FEV1/ FVC)<70 % ; FEV1reversibility after inhalation of 200g salbutamol (bronchodilator) of less than 12 % of prebronchodilator FEV1.
Key inclusion criteria (1 listed)
- chronic respiratory symptom and signs such as cough ,breathlessness , wheeze ; forced expiratory volume in one second(FEV1)of predicted (FEV1%) less than 80 % ; the ratio of FEV1 to forced vital capacity (FVC , FEV1/ FVC)<70 % ; FEV1reversibility after inhalation of 200g salbutamol (bronchodilator) of less than 12 % of prebronchodilator FEV1.
Key exclusion criteria (2 listed)
- Coexistence of asthma and COPD or with earlier history of bronchial asthma as well as patients who have never smoked were excluded from the study.
- -
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
Matrix metalloproteinase-9 gene polymorphism
Time frame: 18 months
Matrix metalloproteinase-9 gene polymorphism by conventional PCR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 37233751Agusti A, Bohm M, Celli B, Criner GJ, Garcia-Alvarez A, Martinez F, Sin DD, Vogelmeier CF. GOLD COPD DOCUMENT 2023: a brief update for practicing cardiologists. Clin Res Cardiol. 2024 Feb;113(2):195-204. doi: 10.1007/s00392-023-02217-0. Epub 2023 May 26.
- Background: PubMed 33419373Cabral-Pacheco GA, Garza-Veloz I, Castruita-De la Rosa C, Ramirez-Acuna JM, Perez-Romero BA, Guerrero-Rodriguez JF, Martinez-Avila N, Martinez-Fierro ML. The Roles of Matrix Metalloproteinases and Their Inhibitors in Human Diseases. Int J Mol Sci. 2020 Dec 20;21(24):9739. doi: 10.3390/ijms21249739.
- Background: PubMed 38166679Cai L, Zuo X, Ma L, Zhang Y, Xu F, Lu B. Associations of MMP9 polymorphism with the risk of severe pneumonia in a Southern Chinese children population. BMC Infect Dis. 2024 Jan 2;24(1):19. doi: 10.1186/s12879-023-08931-4.
- Background: PubMed 35948393Lu Z, Coll P, Maitre B, Epaud R, Lanone S. Air pollution as an early determinant of COPD. Eur Respir Rev. 2022 Aug 10;31(165):220059. doi: 10.1183/16000617.0059-2022. Print 2022 Sep 30.
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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.
Nagwa S Ahmed, professor contact
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 Chronic Obstructive Pulmonary Disease, run by Sohag 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 2 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 16 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasmeen M Ismail, demonastrator (01112564372, yassmin.ismaeal@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matrix metalloproteinase-9 gene polymorphism (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06503315, which also lists 4 linked publications.
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 16 Jul 2024.