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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Peking University Third Hospital
RECRUITING
Beijing
Contact Information
Primary
Ying Liang, M.D.
bysyliangying@126.com
86-01082266699
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 540
Treatments
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.
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.
Sponsors
Leads: Peking University Third Hospital
Collaborators: The First Affiliated Hospital of Guangzhou Medical University, Shanxi Bethune Hospital, West China Hospital, Peking University Shougang Hospital, First Hospital of China Medical University, Tibet Autonomous Region People's Hospital

This content was sourced from clinicaltrials.gov