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

Abstract

Background Both tuberculosis and COPD are major public health problems and pulmonary tuberculosis has been confirmed as an important risk factor for COPD. Tuberculosis participates in the development of COPD through distinctive pathophysiological mechanisms. Tuberculosis-associated COPD is a unique phenotype of COPD and may have distinct characteristics compared to COPD patients without previous tuberculosis history. The precise definition, clinical characteristics, prognosis and optimal pharmacologic intervention of tuberculosis-associated COPD warrant further investigation. Methods This multicenter, prospective, observational cohort study will recruit more than 135 tuberculosis-associated COPD and 405 non-tuberculosis-associated COPD patients aged 35 years or older from 7 tertiary hospitals across mainland China. Diagnosis of tuberculosis-associated COPD is made if any of the following criteria is met: (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 results of interferon gamma release assays accompanied with typical radiological signs. Demographic data, medical history related to COPD, respiratory questionnaires, blood routine examination, interferon gamma release assays, therapeutic regimen, lung function and chest CT will be collected at baseline. Patients will be followed up for 1 year and evaluated at outpatient every 6 months to record the longitudinal changes of symptoms, treatment regimen, lung function and frequency of exacerbation and hospitalization due to COPD. Furthermore, patients can consult their physicians whenever their symptoms get worse. Chest CT and total medical expenditure will be additionally assessed in the last outpatient visit. The study has been approved by Peking University Third Hospital Medical Science Research Ethics Committee (approval number: IRB00006761-M2023573). Discussion This study will provide a detailed characteristic profile of tuberculosis-associated COPD and propose potential treatment options for this specific patient group. Trial registration Registration number in ClinicalTrials.gov: NCT06074042