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

NCT06074042 | Recruiting

• 1 other identifier: M2023573
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

chronic obstructive pulmonary disease (COPD); acute exacerbation of COPD; pulmonary tuberculosis; phenotype

Outcome Measures

Primary Outcomes (1)

• 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: * 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.

  Through study completion, an average of 1 year

Study Arms (2)

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.

Other: previous pulmonary tuberculosis

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.

Interventions

previous pulmonary tuberculosis OTHER

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

tuberculosis-associated COPD

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are recruited from seven hospitals distributed in 6 different provinces of China.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Peking University Shougang Hospital: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• First Hospital of China Medical University: collaborator
• West China Hospital: collaborator
• Shanxi Bethune Hospital: collaborator
• Tibet Autonomous Region People's Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections

Study Officials

• Ying Liang, M.D.

  Peking University Third Hhospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Liang, M.D.

CONTACT

86-01082266699; bysyliangying@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peking University Third Hospital

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 10, 2023
• Study Start: May 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)