RecruitingNCT06074042

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

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


Sponsor

Peking University Third Hospital

Enrollment

540 participants

Start Date

May 1, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 35 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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

Interventions

OTHERprevious pulmonary tuberculosis

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


Locations(1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

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NCT06074042


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