COPDNCT06074042
The Clinical Characteristics, Treatment and Prognosis of Tuberculosis-associated COPD
An observational study of COPD, run by Peking University Third Hospital at 1 site in China.
Trial summary
Chronic obstructive pulmonary disease (COPD) still imposes a substantial health and economic burden worldwide. Pulmonary tuberculosis has been confirmed as an important risk factor for COPD and this specific phenotype is thereby named as "tuberculosis-associated COPD". Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- COPD
- What is being tested?
- previous pulmonary tuberculosis
- How many people
- 540 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 31 Dec 2025
- How long will I take part?
- 1 Year
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are recruited from seven hospitals distributed in 6 different provinces of China.
Who may be able to join
- patients who have dyspnea, chronic cough or sputum production and have definite airflow limitation with a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) <0.7;
- in stable condition;
- aged 35 years or older
Who cannot join
- bronchiectasis, asthma or any other obstructive pulmonary diseases;
- pneumonia or active tuberculosis;
- severe hepatic or renal insufficiency;
- lung cancer or other advanced malignancies;
- acquired immune deficiency due to HIV or chemotherapy;
- severe trauma, operation or stress status in the past one month;
- severe cognitive dysfunction;
- unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Ying Liang, M.D., 86-01082266699, bysyliangying@126.com
About this study
Official title: The Clinical Characteristics, Treatment and Prognosis of Tuberculosis-associated Chronic Obstructive Pulmonary Disease in China: A Multicenter Prospective Cohort Study
Chronic obstructive pulmonary disease (COPD) still imposes a substantial health and economic burden worldwide. Pulmonary tuberculosis has been confirmed as an important risk factor for COPD and this specific phenotype is thereby named as "tuberculosis-associated COPD". Although it is a generally accepted concept, several relevant problems need to be addressed, including how to define this phenotype more precisely, what the clinical characteristics and prognosis are as well as which kind of pharmacologic intervention is optimal.
In this study, tuberculosis-associated COPD patients (study group) and non-tuberculosis associated COPD patients (control group) are recruited. After collecting baseline information of participants, the investigators arrange for participants to follow up in the outpatient for reassessment with a scheduled interval of 6 months, which lasts for 1 year. Primary outcome of this study is the frequency of moderate/severe acute exacerbation of COPD during the follow-up of 12 months. By conducting a multicenter prospective cohort study in China, the researchers intend to investigate the clinical characteristics and prognostic predictors, explore plausible therapeutic regimens and promote precise diagnosis and treatment for tuberculosis-associated COPD.
Read the detailed description
A nationwide, multicenter, prospective, observational cohort study enrolling consecutive tuberculosis-associated COPD patients (study group) and non-tuberculosis associated COPD patients (control group) is designed to conduct across mainland China, in which a total of 7 tertiary hospitals will participate. Stable COPD patients meeting the criteria will be allocated into "tuberculosis-associated COPD group" or "non-tuberculosis associated COPD group" according to the medical history, T cell spot test for tuberculosis infection (T-SPOT.TB) and chest computed tomography (CT) sign. Baseline information of the participants will be collected, including the following items:
- Demographic data. Age, sex, ethnicity, height, weight, residential address, education level and annual household income will be collected;
- Smoking history and medical history associated with pulmonary tuberculosis and COPD;
- Therapeutic regimens for COPD;
- Respiratory symptoms evaluated by the COPD Assessment Test (CAT) score, the modified Medical Research Council (mMRC) dyspnea scale and St George's Respiratory Questionnaire for COPD patients (SGRQ-C);
- Blood routine examination and T-SPOT.TB;
- Lung function. Pre-bronchodilator and post-bronchodilator spirometry function and diffusing capacity are assessed;
- Chest CT. Radiological findings about tuberculosis sequelae include calcification, fibrotic lesions, dense nodules, cavitation or pleural scarring. Severity of emphysema is evaluated by using Goddard score. Severity and extent of bronchiectasis are evaluated by using Smith score and Bhalla score, respectively.
All participants will be prospectively followed up for at least one year in the outpatient of each affiliated hospitals with an interval of 6 months. Alteration of respiratory symptom, lung function and blood routine examination, therapeutic regimen, chest CT, frequency of exacerbation and hospitalization as well as total expenditure associated with COPD will be reevaluated and recorded. The frequency of moderate/severe acute exacerbation of COPD during the follow-up of 12 months is the primary outcome.
Main objectives of this study are about the following aspects:
- Elucidate the clinical characteristics, progression and prognosis of tuberculosis-associated COPD.
- Evaluate the relationship between different drug regimens and the prognosis of tuberculosis-associated COPD, as well as recurrence or deterioration of pulmonary tuberculosis, serving to the personalized medical management.
- Optimize the definition of tuberculosis-associated COPD.
- Conditions
- COPD
- Being tested
- previous pulmonary tuberculosis
- Keywords
- chronic obstructive pulmonary disease (COPD), acute exacerbation of COPD, pulmonary tuberculosis, phenotype
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
previous pulmonary tuberculosisOther
Previous pulmonary tuberculosis is comprehensively evaluated by the self-reported medical history, T-SPOT.TB test and radiological findings.
| Study group | Role | What they receive |
|---|---|---|
| tuberculosis-associated COPD | COPD patient who meets any of the following criteria is diagnosed as tuberculosis-associated COPD:
1. previously definite pulmonary tuberculosis and ever receiving standard antituberculosis therapy;
2. previously suspected pulmonary tuberculosis and having typical radiological findings consistent with tuberculosis sequelae;
3. no definite history of pulmonary tuberculosis but having positive T-SPOT.TB test accompanied with typical radiological findings consistent with tuberculosis sequelae. Receives: Other: previous pulmonary tuberculosis | |
| non-tuberculosis associated COPD | COPD patient in whom neither medical history nor chest CT indicates evidence of pulmonary tuberculosis is diagnosed as non-tuberculosis associated COPD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the frequency of moderate/severe acute exacerbation of COPD during the follow-up of 12 months
Exacerbations of COPD are defined as sustained increase of respiratory symptoms characterized by dyspnea and/or cough and sputum. Classification of severity of COPD exacerbations is as followed:
- Mild. Only monotherapy of short-acting bronchodilator is prescribed for treatment;
- Moderate. Short-acting bronchodilator and antibacterial agents are prescribed combined with oral glucocorticoids or not;
- Severe. Hospitalization or admission to intend care unit (ICU) is required.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 May 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- 540 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Shougang Hospital, The First Affiliated Hospital of Guangzhou Medical University, First Hospital of China Medical University, West China Hospital, Shanxi Bethune Hospital, Tibet Autonomous Region People's Hospital
- Responsible party
- Principal investigator, Liang Ying, Peking University Third Hospital
- Investigators
- Ying Liang, M.D., Principal investigator, Peking University Third Hhospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074042
- Sponsor's protocol ID
- M2023573
- Status last verified
- Apr 2024
- First submitted
- 25 Sep 2023
- Last updated
- 3 Apr 2024
- 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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Characteristics, Treatment and Prognosis of Tuberculosis-associated Chronic Obstructive Pulmonary Disease in China: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06074042
- Acronym / sponsor ID
- M2023573
- Conditions
- COPD
- Keywords
- chronic obstructive pulmonary disease (COPD), acute exacerbation of COPD, pulmonary tuberculosis, phenotype
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Peking University Shougang Hospital, The First Affiliated Hospital of Guangzhou Medical University, First Hospital of China Medical University, West China Hospital, Shanxi Bethune Hospital, Tibet Autonomous Region People's Hospital
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Oct 2023 (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) still imposes a substantial health and economic burden worldwide. Pulmonary tuberculosis has been confirmed as an important risk factor for COPD and this specific phenotype is thereby named as "tuberculosis-associated COPD". Although it is a generally accepted concept, several relevant problems need to be addressed, including how to define this phenotype more precisely, what the clinical characteristics and prognosis are as well as which kind of pharmacologic intervention is optimal.
In this study, tuberculosis-associated COPD patients (study group) and non-tuberculosis associated COPD patients (control group) are recruited. After collecting baseline information of participants, the investigators arrange for participants to follow up in the outpatient for reassessment with a scheduled interval of 6 months, which lasts for 1 year. Primary outcome of this study is the frequency of moderate/severe acute exacerbation of COPD during the follow-up of 12 months. By conducting a multicenter prospective cohort study in China, the researchers intend to investigate the clinical characteristics and prognostic predictors, explore plausible therapeutic regimens and promote precise diagnosis and treatment for tuberculosis-associated COPD.
Detailed description
A nationwide, multicenter, prospective, observational cohort study enrolling consecutive tuberculosis-associated COPD patients (study group) and non-tuberculosis associated COPD patients (control group) is designed to conduct across mainland China, in which a total of 7 tertiary hospitals will participate. Stable COPD patients meeting the criteria will be allocated into "tuberculosis-associated COPD group" or "non-tuberculosis associated COPD group" according to the medical history, T cell spot test for tuberculosis infection (T-SPOT.TB) and chest computed tomography (CT) sign. Baseline information of the participants will be collected, including the following items:
- Demographic data. Age, sex, ethnicity, height, weight, residential address, education level and annual household income will be collected;
- Smoking history and medical history associated with pulmonary tuberculosis and COPD;
- Therapeutic regimens for COPD;
- Respiratory symptoms evaluated by the COPD Assessment Test (CAT) score, the modified Medical Research Council (mMRC) dyspnea scale and St George's Respiratory Questionnaire for COPD patients (SGRQ-C);
- Blood routine examination and T-SPOT.TB;
- Lung function. Pre-bronchodilator and post-bronchodilator spirometry function and diffusing capacity are assessed;
- Chest CT. Radiological findings about tuberculosis sequelae include calcification, fibrotic lesions, dense nodules, cavitation or pleural scarring. Severity of emphysema is evaluated by using Goddard score. Severity and extent of bronchiectasis are evaluated by using Smith score and Bhalla score, respectively.
All participants will be prospectively followed up for at least one year in the outpatient of each affiliated hospitals with an interval of 6 months. Alteration of respiratory symptom, lung function and blood routine examination, therapeutic regimen, chest CT, frequency of exacerbation and hospitalization as well as total expenditure associated with COPD will be reevaluated and recorded. The frequency of moderate/severe acute exacerbation of COPD during the follow-up of 12 months is the primary outcome.
Main objectives of this study are about the following aspects:
- Elucidate the clinical characteristics, progression and prognosis of tuberculosis-associated COPD.
- Evaluate the relationship between different drug regimens and the prognosis of tuberculosis-associated COPD, as well as recurrence or deterioration of pulmonary tuberculosis, serving to the personalized medical management.
- Optimize the definition of tuberculosis-associated COPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tuberculosis-associated COPD | – | Other: previous pulmonary tuberculosisCOPD patient who meets any of the following criteria is diagnosed as tuberculosis-associated COPD: 1. previously definite pulmonary tuberculosis and ever receiving standard antituberculosis therapy; 2. previously suspected pulmonary tuberculosis and having typical radiological findings consistent with tuberculosis sequelae; 3. no definite history of pulmonary tuberculosis but having positive T-SPOT.TB test accompanied with typical radiological findings consistent with tuberculosis sequelae. |
| non-tuberculosis associated COPD | – | –COPD patient in whom neither medical history nor chest CT indicates evidence of pulmonary tuberculosis is diagnosed as non-tuberculosis associated COPD. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are recruited from seven hospitals distributed in 6 different provinces of China.
Key inclusion criteria (3 listed)
- patients who have dyspnea, chronic cough or sputum production and have definite airflow limitation with a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) <0.7;
- in stable condition;
- aged 35 years or older
Key exclusion criteria (8 listed)
- bronchiectasis, asthma or any other obstructive pulmonary diseases;
- pneumonia or active tuberculosis;
- severe hepatic or renal insufficiency;
- lung cancer or other advanced malignancies;
- acquired immune deficiency due to HIV or chemotherapy;
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 |
|---|---|---|
| previous pulmonary tuberculosisPrevious pulmonary tuberculosis is comprehensively evaluated by the self-reported medical history, T-SPOT.TB test and radiological findings. | Other | tuberculosis-associated COPD |
Primary outcome
the frequency of moderate/severe acute exacerbation of COPD during the follow-up of 12 months
Time frame: Through study completion, an average of 1 year
Exacerbations of COPD are defined as sustained increase of respiratory symptoms characterized by dyspnea and/or cough and sputum. Classification of severity of COPD exacerbations is as followed: * Mild. Only monotherapy of short-acting bronchodilator is prescribed for treatment; * Moderate. Short-acting bronchodilator and antibacterial agents are prescribed combined with oral glucocorticoids or not; * Severe. Hospitalization or admission to intend care unit (ICU) is required.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- 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.
Ying Liang, M.D. principal investigator
Peking University Third Hhospital
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 COPD, 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 3 inclusion and 8 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 3 Apr 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Liang, M.D. (86-01082266699, bysyliangying@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the frequency of moderate/severe acute exacerbation of COPD during the follow-up of 12 months (time frame: Through study completion, an average of 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 3 Apr 2024.