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COPD-PTB Screening Trial in Henan, China

NCT07706972 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25000

Last updated 2026-07-16

No results posted yet for this study

Summary

The goal of this trial is to evaluate the effectiveness of an active case-finding (ACF) strategy for detecting pulmonary tuberculosis (PTB) among patients with chronic obstructive pulmonary disease (COPD) in primary care settings in Henan Province, China. It will also assess the epidemiological status of COPD-PTB comorbidity in this population and evaluate the feasibility of the ACF strategy in real-world primary care settings.

This is a stepped-wedge cluster randomized controlled trial. Specifically, the intervention group will receive the ACF strategy in Year 1, Year 2, and Year 3, while the control group will receive routine follow-up care in Year 1 and Year 2, and will transition to receive the ACF intervention in Year 3. All clusters will eventually receive the ACF intervention.

The main questions it aims to answer are:

Does the ACF strategy decrease the prevalence of PTB among COPD patients compared with routine passive case-finding? What are the current prevalence and epidemiological characteristics of COPD-PTB comorbidity in primary care settings in Henan Province?

Participants will:

Receive ACF screening during their routine COPD follow-up visits in the intervention phase.

Continue their usual COPD care as prescribed by their healthcare providers. If diagnosed with PTB through ACF screening, participants will be referred to designated hospitals for treatment in accordance with the national standardized tuberculosis treatment protocol.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)
  • TB - Tuberculosis

Interventions

OTHER

ACF strategy

An ACF strategy integrating computer-aided diagnosis and GeneXpert MTB/RIF testing.

Sponsors & Collaborators

  • Henan Provincial People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2028-12-31
Completion
2029-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07706972 on ClinicalTrials.gov