Chronic Obstructive Pulmonary Disease (COPD)NCT07706972
COPD-PTB Screening Trial in Henan, China
A study testing ACF strategy in people with Chronic Obstructive Pulmonary Disease (COPD) and TB - Tuberculosis, run by Henan Provincial People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), TB - Tuberculosis
- What is being tested?
- ACF strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 30 Jun 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 years or older;
- residence in the local area for at least six months;
- providing written informed consent to participate in the study.
Who cannot join
- inability to provide informed consent or complete the questionnaire;
- contraindications to CT scanning;
- current pregnancy.
About this study
Official title: Epidemiological Status and Intervention Technologies for COPD and Pulmonary Tuberculosis Comorbidity in Primary Care Settings in Henan Province, China
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.
Read more
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.
- Being tested
- ACF strategy
- Keywords
- COPD, TB, active case-finding strategy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACF strategyOther
An ACF strategy integrating computer-aided diagnosis and GeneXpert MTB/RIF testing.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention Group | Experimental | This cluster receives the intervention during Years 1, 2, and 3. Receives: Other: ACF strategy |
| Delayed Intervention Group | Other | This cluster serves as a no-intervention control during Years 1 and 2, and then transitions to receive the same intervention during Year 3. Receives: Other: ACF strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of bacteriologically confirmed PTB
Measured: the third year
Secondary outcomes (1)
Diagnosis delay time
Diagnosis delay is defined as the number of days from the date of the first screening test (e.g., CAD-assisted chest imaging) or the first medical examination for respiratory symptoms (for passive case-finding) to the date of bacteriologically-confirmed PTB diagnosis (positive Xpert MTB/RIF result).
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In Year 1, Arm A receive the intervention while Arm B serves as control. In Year 2, Arm A continues with the intervention, Arm B remains control. In Year 3, both Arm A and Arm B receive the intervention.
- Masking
- None (open label)
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706972
- Sponsor's protocol ID
- 2025-244
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No