PROJECT

Prevalence, pattern and progression of Post TB Lung Disease in India: A prospective single arm study

Jan 2025 - Dec 2027

Objectives:

In the adult new pulmonary TB patients initiated with six months daily regimen under NTEP. Primary Objective: 1. To determine the prevalence, pattern and progression of post TB lung disease (PTLD) during and after two years of successful treatment Secondary Objective: 1. To identify the risk factors of PTLD. 2. To understand the circulating immune markers baseline and longitudinal assessment of PTLD. 3. To understand the psychosocial and economic challenges faced by the PTLD participants at the end of treatment.

Study Overview:

This study, titled “Prevalence, Pattern and Progression of Post TB Lung Disease (PTLD) in India: A Prospective Single Arm Study”, aims to evaluate the burden and evolution of post-TB lung disease among newly diagnosed drug-sensitive pulmonary tuberculosis patients treated under the National Tuberculosis Elimination Programme (NTEP). The study focuses on understanding the prevalence, clinical and functional patterns, progression, and risk factors of PTLD during treatment and up to two years after successful TB treatment completion. It also seeks to assess immunological markers associated with PTLD and explore the psychosocial and economic challenges faced by affected patients. The study will be conducted at NIRT clinic sites in Chennai, Madurai, and Vellore using a prospective single-arm design involving 177 adult pulmonary TB patients.

Study Approach:

The study uses a prospective single-arm cohort design with consecutive enrolment of eligible PTB patients. Participants will be followed longitudinally at baseline, 3, 6, 12, 18, 24, and 30 months. Participants will undergo: • Clinical evaluation • Spirometry (pre- and post-bronchodilator) • Forced Oscillation Technique (FOT) • Chest X-ray and HRCT • 6-Minute Walk Test (6MWT) • St. George’s Respiratory Questionnaire (SGRQ) PTLD is operationally defined as any abnormal finding in pulmonary function tests or FOT suggestive of restrictive, obstructive, or mixed lung disease

Expected Public Health Impact:

1.Improved understanding of PTLD burden • Quantification of prevalence and progression of lung impairment after TB treatment across multiple time points. 2.Early identification and rehabilitation • Identification of clinical, radiological, and immunological predictors may enable early diagnosis and targeted rehabilitation strategies. 3.Evidence for policy and programme strengthening • Findings will help NTEP programme managers develop structured post-TB care and long-term monitoring strategies. 4.Advancement in host-directed therapies. • Immunological insights may support development of biomarkers and future host-directed therapeutic interventions. 5.Addressing psychosocial and economic consequences • The qualitative component will provide evidence on stigma, mental health, livelihood disruption, and rehabilitation needs, informing patient-centred TB care models. 6.Contribution to global PTLD research • Global understanding of post-TB lung health.