Chronic Obstructive Pulmonary DiseaseNCT04952883
Hydrogen Sulfide and Pulmonary Vascular Remodeling on HRCT in Patients With COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Peking University Third Hospital at 1 site in China.
Trial summary
HRCT was used to evaluate pulmonary vascular remodeling in COPD. The role of H2S in pulmonary vascular remodeling in COPD was analyzed, in order to provide a basis for seeking new therapeutic targets. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2016to 1 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Outpatient with stable chronic obstructive pulmonary disease
Who may be able to join
- Patients meet the GOLD 2016 guidelines for diagnostic criteria of COPD: dyspnea, chronic cough and/or sputum symptoms, exposure to risk factors, and pulmonary function after inhalation of bronchodilator with forced expiratory volume (FEV1)/forced vital capacity (FVC) < 70%.
Who cannot join
- 1. Other lung diseases such as pneumonia, lung cancer, tuberculosis, pulmonary embolism, heart diseases such as heart failure, ventricular septal defect, patent ductus arteriosus, thoracic deformity and pleural diseases.
- 2. Patients who are unable to understand and/or complete questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-sectional Study of Endogenous Hydrogen Sulfide and Pulmonary Vascular Remodeling on HRCT in Patients With Chronic Obstructive Pulmonary Disease
HRCT was used to evaluate pulmonary vascular remodeling in COPD. The role of H2S in pulmonary vascular remodeling in COPD was analyzed, in order to provide a basis for seeking new therapeutic targets.
Read the detailed description
This study aimed to investigate the relationship between endogenous H2S and pulmonary vascular remodeling on HRCT in patients with COPD through the determination of H2S and its synthase mRNA levels in blood and pulmonary vessels by HRCT, to evaluate the role of H2S in pulmonary vascular remodeling in COPD and to provide a basis for seeking new therapeutic targets. This study had predictive value for clinical prognosis of patients. It had important clinical guiding significance and social and economic benefit to comprehensively understand the pathogenesis of COPD.
- 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 |
|---|---|---|
| COPD patients | The COPD questionnaire was conducted to collect the data of lung function, echocardiography and blood gas analysis, and the pulmonary vessels of HRCT were determined. Blood samples were collected for H2S-related indicators detection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of H2S and its synthase nucleic acid and pulmonary vascular remodeling indexes on HRCT in COPD patients
Measured: 1 year
Secondary outcomes (1)
Relationship between plasma H2S and its synthase nucleic acid levels and pulmonary vascular remodeling indexes on HRCT in patients with COPD
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Dec 2016
- Primary completion1 Sep 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yahong Chen, PHD, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952883
- Sponsor's protocol ID
- LM2016099
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study of Endogenous Hydrogen Sulfide and Pulmonary Vascular Remodeling on HRCT in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04952883
- Acronym / sponsor ID
- LM2016099
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 7 Jul 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.
HRCT was used to evaluate pulmonary vascular remodeling in COPD. The role of H2S in pulmonary vascular remodeling in COPD was analyzed, in order to provide a basis for seeking new therapeutic targets.
Detailed description
This study aimed to investigate the relationship between endogenous H2S and pulmonary vascular remodeling on HRCT in patients with COPD through the determination of H2S and its synthase mRNA levels in blood and pulmonary vessels by HRCT, to evaluate the role of H2S in pulmonary vascular remodeling in COPD and to provide a basis for seeking new therapeutic targets. This study had predictive value for clinical prognosis of patients. It had important clinical guiding significance and social and economic benefit to comprehensively understand the pathogenesis of COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients | – | –The COPD questionnaire was conducted to collect the data of lung function, echocardiography and blood gas analysis, and the pulmonary vessels of HRCT were determined. Blood samples were collected for H2S-related indicators detection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatient with stable chronic obstructive pulmonary disease
Key inclusion criteria (1 listed)
- Patients meet the GOLD 2016 guidelines for diagnostic criteria of COPD: dyspnea, chronic cough and/or sputum symptoms, exposure to risk factors, and pulmonary function after inhalation of bronchodilator with forced expiratory volume (FEV1)/forced vital capacity (FVC) < 70%.
Key exclusion criteria (2 listed)
- 1. Other lung diseases such as pneumonia, lung cancer, tuberculosis, pulmonary embolism, heart diseases such as heart failure, ventricular septal defect, patent ductus arteriosus, thoracic deformity and pleural diseases.
- 2. Patients who are unable to understand and/or complete questionnaire.
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
Plasma levels of H2S and its synthase nucleic acid and pulmonary vascular remodeling indexes on HRCT in COPD patients
Time frame: 1 year
1 secondary outcome
Relationship between plasma H2S and its synthase nucleic acid levels and pulmonary vascular remodeling indexes on HRCT in patients with COPD
Time frame: 1 year
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 12 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
Yahong Chen, PHD study chair
Peking University Third 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 Chronic Obstructive Pulmonary Disease, run by Peking University Third 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 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: finished, as of the sponsor's last update on 12 Jul 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 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?
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?
Plasma levels of H2S and its synthase nucleic acid and pulmonary vascular remodeling indexes on HRCT in COPD patients (time frame: 1 year). 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 12 Jul 2021.