The Clinical Characteristics, Treatment and Prognosis of Tuberculosis-associated COPD

Sponsor

Peking University Third Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06074042

Collaborator

Peking University Shougang Hospital (Other), The First Affiliated Hospital of Guangzhou Medical University (Other), First Hospital of China Medical University (Other), West China Hospital (Other), Shanxi Bethune Hospital (Other), Tibet Autonomous Region People's Hospital (Other)

540

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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". 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.

Condition or Disease	Intervention/Treatment	Phase
COPD	Other: previous pulmonary tuberculosis

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

540 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Clinical Characteristics, Treatment and Prognosis of Tuberculosis-associated Chronic Obstructive Pulmonary Disease in China: A Multicenter Prospective Cohort Study

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
tuberculosis-associated COPD COPD patient who meets any of the following criteria is diagnosed as tuberculosis-associated COPD: previously definite pulmonary tuberculosis and ever receiving standard antituberculosis therapy; previously suspected pulmonary tuberculosis and having typical radiological findings consistent with tuberculosis sequelae; no definite history of pulmonary tuberculosis but having positive T-SPOT.TB test accompanied with typical radiological findings consistent with tuberculosis sequelae.	Other: previous pulmonary tuberculosis Previous pulmonary tuberculosis is comprehensively evaluated by the self-reported medical history, T-SPOT.TB test and radiological findings.
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.

Arm

Intervention/Treatment

tuberculosis-associated COPD

COPD patient who meets any of the following criteria is diagnosed as tuberculosis-associated COPD: previously definite pulmonary tuberculosis and ever receiving standard antituberculosis therapy; previously suspected pulmonary tuberculosis and having typical radiological findings consistent with tuberculosis sequelae; no definite history of pulmonary tuberculosis but having positive T-SPOT.TB test accompanied with typical radiological findings consistent with tuberculosis sequelae.

Other: previous pulmonary tuberculosis

Previous pulmonary tuberculosis is comprehensively evaluated by the self-reported medical history, T-SPOT.TB test and radiological findings.

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.

Outcome Measures

Primary Outcome Measures

the frequency of moderate/severe acute exacerbation of COPD during the follow-up of 12 months [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Peking University Third Hospital
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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Liang Ying, Peking University Third Hospital, Peking University Third Hospital

ClinicalTrials.gov Identifier:

NCT06074042

Other Study ID Numbers:

M2023573

First Posted:

Oct 10, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Liang Ying, Peking University Third Hospital, Peking University Third Hospital

chronic obstructive pulmonary disease (COPD)

acute exacerbation of COPD

pulmonary tuberculosis

phenotype

Additional relevant MeSH terms:

Tuberculosis

Study Results

No Results Posted as of Oct 10, 2023