Pulmonary Disease, Chronic ObstructiveNCT04964076
Clinical Phenotypes of COPD Patients Between in Plateau and Plain
An observational study of Pulmonary Disease, Chronic Obstructive, run by Peking University Third Hospital at 1 site in China.
Trial summary
We aimed to collect clinical and radiological data of patients with stable COPD in plateau and plain, and compare the clinical phenotypic characteristics and imaging features of COPD patients in these two areas. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 31 Dec 2021
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We consecutively enrolled patients with COPD from January 2018 to December 2021, who visited the outpatient of Department of Respiratory Medicine in Peking University Third Hospital or Tibet Autonomous Region People's Hospital.
Who may be able to join
- meeting the diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and had definite airflow limitation with a post-bronchodilator forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC)<0.7.
Who cannot join
- age <40 years;
- subjects with airway diseases other than COPD;
- acute exacerbation of COPD in the past 3 months;
- active tuberculosis;
- cardiovascular or cerebrovascular events in the past 3 months;
- cognitive dysfunction such as vascular dementia or Alzheimer's disease;
- refusal to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Clinical and Radiological Phenotypes of Patients With Stable COPD Between in Plateau and Plain
We aimed to collect clinical and radiological data of patients with stable COPD in plateau and plain, and compare the clinical phenotypic characteristics and imaging features of COPD patients in these two areas.
Read the detailed description
The purpose of this study was to investigate the clinical phenotypic characteristics and imaging features of patients with stable chronic obstructive pulmonary disease (COPD) in plateau and plain. We conducted a cross-sectional study, collecting clinical data of stable patients in plateau and plain, and comparing the clinical phenotypic characteristics and imaging features of COPD patients in these two areas.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- No intervention
- 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.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| COPD patients in the plateau | We consecutively enrolled COPD patients visiting the outpatient of Respiratory Medicine at Tibet Autonomous Region People's Hospital from January 2018 to December 2021. Receives: Other: No intervention | |
| COPD patients in the plain | We consecutively enrolled COPD patients visiting the outpatient of Respiratory Medicine at Peking University Third Hospital from January 2018 to December 2021. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of respiratory symptoms
COPD Assessment Test
Measured: Data were obtained during the interview.
Exacerbation
Frequency of exacerbations in the past year
Measured: Data were obtained during the interview.
Spirometry testing
FEV1 %predicted, FVC %predicted, ratio of FEV1/FVC
Measured: Data were obtained during the interview.
Emphysema
The percentage of the LAA divided by total lung volumes (LAA%) was used as an index of the severity of emphysema in quantitative CT examination.
Measured: Within 3 months of the interview.
Airway remodeling -1
Bronchial wall thickness (WT, mm) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.
Measured: Within 3 months of the interview.
Airway remodeling -2
Luminal area (LA, mm2) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.
Measured: Within 3 months of the interview.
Airway remodeling -3
Bronchial wall area (WA, mm2) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.
Measured: Within 3 months of the interview.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Nov 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 104 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tibet Autonomous Region People's Hospital
- Responsible party
- Principal investigator, Sun Yongchang, Peking University Third Hospital
- Investigators
- Yongchang Sun, M.D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964076
- Sponsor's protocol ID
- LM2020390
- Status last verified
- Nov 2023
- First submitted
- 29 Jun 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Phenotypes of Patients With Stable COPD Between in Plateau and Plain
- ClinicalTrials.gov ID
- NCT04964076
- Acronym / sponsor ID
- LM2020390
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Tibet Autonomous Region People's Hospital
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 15 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.
We aimed to collect clinical and radiological data of patients with stable COPD in plateau and plain, and compare the clinical phenotypic characteristics and imaging features of COPD patients in these two areas.
Detailed description
The purpose of this study was to investigate the clinical phenotypic characteristics and imaging features of patients with stable chronic obstructive pulmonary disease (COPD) in plateau and plain. We conducted a cross-sectional study, collecting clinical data of stable patients in plateau and plain, and comparing the clinical phenotypic characteristics and imaging features of COPD patients in these two areas.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients in the plateau | – | Other: No interventionWe consecutively enrolled COPD patients visiting the outpatient of Respiratory Medicine at Tibet Autonomous Region People's Hospital from January 2018 to December 2021. |
| COPD patients in the plain | – | Other: No interventionWe consecutively enrolled COPD patients visiting the outpatient of Respiratory Medicine at Peking University Third Hospital from January 2018 to December 2021. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We consecutively enrolled patients with COPD from January 2018 to December 2021, who visited the outpatient of Department of Respiratory Medicine in Peking University Third Hospital or Tibet Autonomous Region People's Hospital.
Key inclusion criteria (1 listed)
- meeting the diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and had definite airflow limitation with a post-bronchodilator forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC)<0.7.
Key exclusion criteria (7 listed)
- age <40 years;
- subjects with airway diseases other than COPD;
- acute exacerbation of COPD in the past 3 months;
- active tuberculosis;
- cardiovascular or cerebrovascular events in the past 3 months;
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 |
|---|---|---|
| No interventionNo intervention | Other | COPD patients in the plain, COPD patients in the plateau |
Primary outcome
Assessment of respiratory symptoms
Time frame: Data were obtained during the interview.
COPD Assessment Test
Exacerbation
Time frame: Data were obtained during the interview.
Frequency of exacerbations in the past year
Spirometry testing
Time frame: Data were obtained during the interview.
FEV1 %predicted, FVC %predicted, ratio of FEV1/FVC
Emphysema
Time frame: Within 3 months of the interview.
The percentage of the LAA divided by total lung volumes (LAA%) was used as an index of the severity of emphysema in quantitative CT examination.
Airway remodeling -1
Time frame: Within 3 months of the interview.
Bronchial wall thickness (WT, mm) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.
Airway remodeling -2
Time frame: Within 3 months of the interview.
Luminal area (LA, mm2) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.
Airway remodeling -3
Time frame: Within 3 months of the interview.
Bronchial wall area (WA, mm2) was used as one of the measurements for assessment of airway remodeling in quantitative CT examination.
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 18 Nov 2023.
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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.
Yongchang Sun, M.D. principal investigator
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 Pulmonary Disease, Chronic Obstructive, 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 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 18 Nov 2023. 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?
Assessment of respiratory symptoms (time frame: Data were obtained during the interview.). The study lists 7 primary outcomes in all. 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 18 Nov 2023.