Not Yet RecruitingNot Applicable

Mechanisms, Biomarkers and Pulmonary Rehabilitation in Post-TB Lung Disease

760 participantsStarted 2027-01

Plain-language summary

Tuberculosis (TB) affects millions of people worldwide, and many individuals continue to experience long-term health problems even after completing TB treatment. One of the most important of these complications is post-tuberculosis lung disease (PTLD), which can cause persistent breathing problems, reduced physical capacity, and poor quality of life. Despite its high burden, PTLD is still poorly understood, and effective strategies for prevention, early detection, and long-term management are limited. The AFTER-TB study aims to address these gaps by combining long-term follow-up of people with TB with the evaluation of pulmonary rehabilitation (PR) strategies for those who develop PTLD. The study includes three groups: people with active TB who are followed over time, people with established PTLD, and healthy individuals without TB to provide basal values. By following people from the start of TB treatment, the study will identify who develops PTLD and which clinical, biological, and imaging factors contribute to lung damage or recovery. In addition, the study will collect detailed information on symptoms, lung function, imaging, and biological samples over time. Advanced laboratory techniques will be used to identify biomarkers linked to disease progression or protection, as well as bacterial genetic factors that may influence long-term lung outcomes. This information will help improve early diagnosis and risk stratification. AFTER-TB study will also implement a comprehensive pulmonary rehabilitation programme that includes exercise training, respiratory physiotherapy, education for healthy habits, and psychosocial support. The impact of rehabilitation on physical capacity, lung function, and quality of life will be assessed over time. Overall, the AFTER-TB study combines clinical follow-up, biological research, and pulmonary rehabilitation to generate new knowledge that can improve the prevention and management of PTLD, ultimately supporting better long-term health and quality of life for TB survivors.

Who can participate

Age range

5 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \*Criteria aplicable to all participants:\* * Ability and willingness to provide written informed consent (or assent with parental/legal guardian consent for minors). * Willingness and ability to comply with study procedures and scheduled visits. * Willingness and ability to participate in a pulmonary rehabilitation programme, including: supervised exercise, respiratory physiotherapy, health education and psychosocial support. * Enrolment at one of the participating study sites. \*COHORT 1: People with pulmonary tuberculosis\* * Diagnosis of pulmonary TB confirmed by bacteriological methods (genotypic or phenotypic assays). * Drug-susceptible or drug-resistant TB are both eligible. * Initiation of anti-TB treatment within ≤14 days prior to enrolment. * Identified through passive, active or intensified case finding strategies, including healthcare facilities, contact tracing, or community screening. \*COHORT 2: People with PTLD\* * History of bacteriologically confirmed pulmonary TB and completion of anti-TB treatment. * No evidence of active TB disease at the time of enrolment. * Enrolment must occur within 6 months after completion of TB treatment, or at study entry if the participant already has a previously established diagnosis of PTLD. * Presence of post-tuberculosis lung disease (PTLD), defined as abnormalities in at least two of the following domains: * \_Impaired lung function\_ * \_Persistent respiratory symptoms (e.g., cough, dyspnoea)\_ * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in exercise capacity, measured by the Incremental Shuttle Walk Test (6ISWT)

Timeframe: Baseline, month 3 (end of the PR programme) and at 6- and 12-month follow-up

Change in health-related Quality of Life (QoL) questionnaire: WHOQOL-BREF adults, PedsQL 4.0 in children and complemented by an age-adapted SGRQ in adolescents.

Timeframe: From baseline to month 12 of follow-up.

Trial details

NCT IDNCT07731009

SponsorJose Antonio Dominguez Benitez

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-06

Contact for this trial

Jose Dominguez

+34 935 54 30 50 jadominguez@igtp.cat

View on ClinicalTrials.gov More Post Tuberculosis trials