Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking University Shougang Hospital | OTHER |
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
| First Hospital of China Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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:
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tuberculosis-associated COPD | COPD patient who meets any of the following criteria is diagnosed as tuberculosis-associated COPD:
|
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| previous pulmonary tuberculosis | Other | Previous pulmonary tuberculosis is comprehensively evaluated by the self-reported medical history, T-SPOT.TB test and radiological findings. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Through study completion, an average of 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants are recruited from seven hospitals distributed in 6 different provinces of China.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Liang, M.D. | Contact | 86-01082266699 | bysyliangying@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Liang, M.D. | Peking University Third Hhospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| West China Hospital |
| OTHER |
| Shanxi Bethune Hospital | OTHER |
| Tibet Autonomous Region People's Hospital | OTHER |
Not provided
Not provided
Not provided
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |