Respiratory Health and Wellbeing Post Pulmonary Tuberculosis

NCT07178860 | Recruiting DMC

• 1 other identifier: 25009
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

We know that in low-income countries where there is a lot of tuberculosis (TB) about 20%-50% of people treated for TB have long term problems with their lungs and general wellbeing. This means they can't always get back to doing activities they were doing before they had TB and may need further treatment, for example antibiotics, inhalers or special rehabilitation classes. Some people are unnecessarily treated again for TB because they still have a cough. There have been two international guides published recently, describing standards for providing follow up care for people treated for TB. However, in the UK despite there being 4000 new cases of TB diagnosed every year, we do not follow these guidelines and we do not know if people treated for TB here have similar residual problems with their lungs and general wellbeing. It is difficult to advocate for people treated for TB to have follow up care if we do not know the size of the problem. Anecdotally, experts who do the clinics report that there are a large percentage of people who go on to have long term health problems after they are "cured" from TB but there is no pathway to follow them up. There are no UK guidelines or funding to support TB follow-up or ongoing treatment. It is possible, extrapolating from the data from other countries, that 2000 people a year in UK have undiagnosed or untreated lung health problems because of their previous TB. We would like to see if people who are treated in the Liverpool TB service (a regional referral service) have long term problems with their lungs. We will do this by inviting people who were treated for TB to come for a review at approximately 1 year after finishing their treatment. We will ask them to blow into a lung function testing machine (the same that is used for diagnosing asthma) and ask them questions about their health and wellbeing. If they have cough, we will ask them for a sputum sample, and we will collect a blood sample if people are willing to donate a small amount of blood to be used in future research. These will be stored in a special freezer for future related studies into biomarkers and mechanisms of disease. We will also invite some people to partake in recorded interviews where they can give their opinion about how they feel having been treated for TB and what (if any) follow up they feel they would benefit from. We hope that by recording the problems (if any) the people treated for TB have, we will then be able to use this data to design a larger UK-wide study investigating the prevalence of lung disease after treatment for TB. If we find that there is significant disease, in future we can then test treatment options and care pathways, as well as advocate for people to have improved follow up rather than just living with chronic lung health issues that might impair how well they can live their lives.

Conditions

Tuberculosis (TB)

Keywords

Post-TB; TB; Tuberculosis; Post-tuberculosis

Outcome Measures

Primary Outcomes (1)

• Abnormal Fev1

  To describe the prevalence of abnormal lung function in survivors of pulmonary-TB, 1 year after TB treatment completion.

  Approximately 12 month Post TB treatment completion

Eligibility Criteria

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

Study Population

Adult who have completed treatment for Pulmonary TB

You may qualify if:

• \) Adults (over 18 years old) 2) Able to provide written informed consent 3) Previous diagnosis of microbiologically confirmed pulmonary TB 4) Completed TB treatment less than or equal to 18 months ago

You may not qualify if:

• \) Previously diagnosed clinically significant chronic lung disease that is not well-controlled (for example COPD on significant treatment, or poorly controlled asthma) 2) Unable to perform spirometry due to contraindications to spirometry 3) Under the age of 18 years at the time of recruitment (not the time of initial diagnosis) 4) Incomplete history of TB treatment

Sponsors & Collaborators

• Liverpool School of Tropical Medicine: lead
• Liverpool University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Liverpool School of Tropical Medicine

Liverpool, L35QA, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and sputum

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Rebecca Nightingale, PhD

CONTACT

07702812183; rebecca.nightingale@lstmed.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

GB (1)