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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Status and Intervention Technologies for COPD and Pulmonary Tuberculosis Comorbidity in Primary Care Settings in Henan Province, China
- ClinicalTrials.gov ID
- NCT07706972
- Acronym / sponsor ID
- 2025-244
- Keywords
- COPD, TB, active case-finding strategy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Group | Experimental | Other: ACF strategyThis cluster receives the intervention during Years 1, 2, and 3. |
| Delayed Intervention Group | Other | Other: ACF strategyThis cluster serves as a no-intervention control during Years 1 and 2, and then transitions to receive the same intervention during Year 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 years or older;
- residence in the local area for at least six months;
- providing written informed consent to participate in the study.
Key exclusion criteria (3 listed)
- inability to provide informed consent or complete the questionnaire;
- contraindications to CT scanning;
- current pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACF strategyAn ACF strategy integrating computer-aided diagnosis and GeneXpert MTB/RIF testing. | Other | Delayed Intervention Group, Immediate Intervention Group |
Primary outcome
The prevalence of bacteriologically confirmed PTB
Time frame: the third year
1 secondary outcome
Diagnosis delay time
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ACF strategy in people with Chronic Obstructive Pulmonary Disease (COPD) and TB - Tuberculosis, run by Henan Provincial People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of bacteriologically confirmed PTB (time frame: the third year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.