Treatment outcome among Post TB COPD labelled patients: A prospective cohort study

Study Synopsis

A. Title: Treatment outcome among Post TB COPD labelled patients: A prospective cohort study

B. Background

Approximately 10 million cases of Pulmonary TB are diagnosed every year of which 85% are cured (1). In 2020 there were an estimated 155 million TB survivors and India is likely to have 36-400 million TB survivors. Evidence suggests that a significant proportion of TB treated patients develop post TB lung disease i.e., Chronic Obstructive Pulmonary Disease (COPD). A study called the Post TB spirometry study conducted through the Respiratory Research Network (RRN), in Pune across 27 centers in India, identified 54% of COPD patients amongst the TB treated cohort in the past. Interestingly, of the total cohort 26% were identified as PRISm (Preserved Ratio Impaired Spirometry), which will eventually develop into COPD in the future (to be published).

Even with the increasing burden of Post TB COPD, an appropriate pharmacotherapy is still not known. Through this prospective observational study, various pharmacotherapy will be explored and the most appropriate treatment will be identified by studying the effect of various treatment options on outcomes such as improvement in symptoms, quality of life, decreased number of exacerbations, need for rescue medication, improvement in spirometry and lung oscillometry values.

C. Research Question: What are the treatment outcomes among Post TB COPD .

D. Aim of the Study:

•To study the treatment outcomes among Post TB COPD labelled patients.

E. Study Design: Real world, observational, longitudinal follow-up study

F.Sample Size: 200 Post TB COPD patients

G.Study Population:

Patients of post TB COPD: Adult (>18 years) Male and female subjects previously diagnosed with Pulmonary TB (diagnosis based on Sputum Exam, Chest Xray, HRCT (if available) or other immunological tests) and who have taken full treatment, diagnosed as treatment cure by the treating physician, advised to stop anti-TB treatment. These patients continue to have respiratory symptoms (cough, shortness of breath, sputum) and spirometry shows presence of fixed airflow obstruction (Post-bronchodilator FEV1/FVC < 70%) (these patients will include smokers and non-smokers, drug resistant TB, not drug resistant and then do a sub-group analysis).

Inclusion Criteria

1.Male and female participants ≥18 years of age

2.Diagnosed cases of Post TB COPD (cured from TB)

3.Spirometry FEV1/FVC < 70% (post BD)

4.Patients with respiratory symptoms

Exclusion criteria

1.Participants below the age of 18 years

2.Participants unable to perform spirometry or/and lung oscillometry.

3.Participants not willing to provide consent to participate.

4.Relapse case of TB (Physician defined)

5.TB patients who are on Koch’s treatment

6.Cases of Asthma or all those who have not developed COPD post TB recovery

H.Study Design:

Patients fulfilling the criteria of Post TB COPD will be included into the study. The treating physician will decide what pharmacotherapy needs to be given.

Post TB COPD treatment:

1.No Treatment

2.Inhalation treatment (potential prescriptions that could be prescribed)

•SABA

•SABA+SAMA

•LAMA

•LABA+LAMA

•ICS+LABA

•ICS+LABA+LAMA

3.Other treatment

Baseline values (symptoms, quality of life, exacerbations, need for rescue medication, spirometry, lung oscillometry if available) and follow up changes will be noted during the follow up visits (preferably 1 month and 3 months after starting the treatment). All relevant information will be collected during the study period.

End points: Change in symptoms, quality of life, exacerbations, need for hospital visit or hospitalizations, spirometry and oscillometry parameters will be captured (preferably 1 month and 3 months after starting the treatment)

J.Statistical analysis plan

The primary objective of this study is to report the efficacy and safety of different pharmacotherapies prescribed in patients with Post TB COPD. Descriptive statistics which mainly includes frequency and percentages for all categorical variables, and mean and standard deviation for continuous variables. Differences between baseline values and different time points will be captured using paired t tests. Comparisons between different treatment regiments will be described descriptively.