Chronic Obstructive Pulmonary DiseaseNCT04953611
Quantitative Study on HRCT Phenotype of COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Peking University Third Hospital at 1 site in China.
Trial summary
To explore the HRCT phenotype of the combined COPD assessment staging system Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2013to 30 Nov 2014
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: consecutive outpatients
Who may be able to join
- Age between 40 and 80 (including 40 and 80)
- It meets the diagnostic criteria for COPD
- No language communication barriers, or the family members who know the condition can complete the questionnaire on behalf of the patient, and the data are reliable;
- Voluntarily agree to participate in this study
Who cannot join
- Older than 80 or younger than 40
- Pregnant women
- Complicating with other lung diseases, such as asthma, pneumonia, bronchiectasis, lung abscess, interstitial lung disease, confirmed and suspected lung cancer of lung shadow, active pulmonary tuberculosis, etc
- Previous lung surgery
- Cognitive dysfunction
- Unable to cooperate with lung function test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Study on HRCT Phenotype of the GOLD COPD Assessment Staging
To explore the HRCT phenotype of the combined COPD assessment staging system
Read the detailed description
HRCT can be rapidly and safely deployed has enabled COPD research to move beyond FEV1 by facilitating and amplifying clinical phenotyping measurements, providing quantitative information, and detecting significant responses to therapy even in the absence of significant FEV1 improvements.
We explore the HRCT phenotype of the combined COPD assessment staging system,and found that:
- Airway remodeling occurs in COPD patients. CT shows varying degrees of bronchial wall thickness, area increasing and emphysema as the new GOLD classification Group A-D arising.
- The GOLD Combined assessment staging system helps doctors choose an individualized treatment for the COPD patients
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary disease; chronic obstructive; Phenotype
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
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 |
|---|---|---|
| Group A in GOLD | CAT<10、mMRC 0-1、FEV1%≥50%、the frequency of acute exacerbations in the past year<2； | |
| Group B in GOLD | CAT≥10、mMRC≥2、FEV1%≥50%、the frequency of acute exacerbations in the past year<2 | |
| Group C in GOLD | CAT<10、mMRC 0-1、 FEV1%<50%、the frequency of acute exacerbations in the past year≥2 or leading to hospital admission≥1 | |
| Group D in GOLD | CAT≥10、mMRC≥2、FEV1%<50%、the frequency of acute exacerbations in the past year≥2 or leading to hospital admission≥1 | |
| Control Group | not COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of emphysema
% low attenuation area <950 HU (LAA %)
Measured: Within an average of 3 days after diagnosis of COPD
Indicator A of the severity of airway stenosis
The inner diameter of bronchial (LD) in centimeter
Measured: Within an average of 3 days after diagnosis of COPD
Indicator B of the severity of airway stenosis
The bronchial wall thickness in centimeter
Measured: Within an average of 3 days after diagnosis of COPD
Indicator C of the severity of airway stenosis
Ratio of thickness and outer diameter (TDR)
Measured: Within an average of 3 days after diagnosis of COPD
Indicator D of the severity of airway stenosis
% wall area for bronchial external diameter (WA%)
Measured: Within an average of 3 days after diagnosis of COPD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jul 2013
- Primary completion30 Nov 2014
- Study completion30 Nov 2014
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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953611
- Sponsor's protocol ID
- 2013116
- Status last verified
- Jun 2021
- First submitted
- 1 Jul 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Study on HRCT Phenotype of the GOLD COPD Assessment Staging
- ClinicalTrials.gov ID
- NCT04953611
- Acronym / sponsor ID
- 2013116
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary disease; chronic obstructive; Phenotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 30 Nov 2014 (actual)
- Study completion
- 30 Nov 2014 (actual)
- First posted
- 8 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.
To explore the HRCT phenotype of the combined COPD assessment staging system
Detailed description
HRCT can be rapidly and safely deployed has enabled COPD research to move beyond FEV1 by facilitating and amplifying clinical phenotyping measurements, providing quantitative information, and detecting significant responses to therapy even in the absence of significant FEV1 improvements.
We explore the HRCT phenotype of the combined COPD assessment staging system,and found that:
- Airway remodeling occurs in COPD patients. CT shows varying degrees of bronchial wall thickness, area increasing and emphysema as the new GOLD classification Group A-D arising.
- The GOLD Combined assessment staging system helps doctors choose an individualized treatment for the COPD patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A in GOLD | – | –CAT<10、mMRC 0-1、FEV1%≥50%、the frequency of acute exacerbations in the past year<2； |
| Group B in GOLD | – | –CAT≥10、mMRC≥2、FEV1%≥50%、the frequency of acute exacerbations in the past year<2 |
| Group C in GOLD | – | –CAT<10、mMRC 0-1、 FEV1%<50%、the frequency of acute exacerbations in the past year≥2 or leading to hospital admission≥1 |
| Group D in GOLD | – | –CAT≥10、mMRC≥2、FEV1%<50%、the frequency of acute exacerbations in the past year≥2 or leading to hospital admission≥1 |
| Control Group | – | –not COPD |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive outpatients
Key inclusion criteria (4 listed)
- Age between 40 and 80 (including 40 and 80)
- It meets the diagnostic criteria for COPD
- No language communication barriers, or the family members who know the condition can complete the questionnaire on behalf of the patient, and the data are reliable;
- Voluntarily agree to participate in this study
Key exclusion criteria (6 listed)
- Older than 80 or younger than 40
- Pregnant women
- Complicating with other lung diseases, such as asthma, pneumonia, bronchiectasis, lung abscess, interstitial lung disease, confirmed and suspected lung cancer of lung shadow, active pulmonary tuberculosis, etc
- Previous lung surgery
- Cognitive dysfunction
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 severity of emphysema
Time frame: Within an average of 3 days after diagnosis of COPD
% low attenuation area <950 HU (LAA %)
Indicator A of the severity of airway stenosis
Time frame: Within an average of 3 days after diagnosis of COPD
The inner diameter of bronchial (LD) in centimeter
Indicator B of the severity of airway stenosis
Time frame: Within an average of 3 days after diagnosis of COPD
The bronchial wall thickness in centimeter
Indicator C of the severity of airway stenosis
Time frame: Within an average of 3 days after diagnosis of COPD
Ratio of thickness and outer diameter (TDR)
Indicator D of the severity of airway stenosis
Time frame: Within an average of 3 days after diagnosis of COPD
% wall area for bronchial external diameter (WA%)
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 8 Jul 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 4 inclusion and 6 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 8 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?
The severity of emphysema (time frame: Within an average of 3 days after diagnosis of COPD). The study lists 5 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 8 Jul 2021.