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A BSTRACT Background and Aim: The National Tuberculosis Elimination Program (NTEP) has been progressive in addressing the issues related to tuberculosis (TB) control in the country, with constant programmatic changes based on evidence available from operational research. Our objectives were 1. to assess the sociodemographic and clinical characteristics, and the treatment outcomes of patients on fixed-dose combination (FDC) daily regimen and 2. to assess the factors associated with unsuccessful treatment outcomes among patients with DS-TB. Materials and Methods: A retrospective cohort study was conducted based on record review. The study population included all patients with drug-sensitive TB, registered and initiated on treatment under NTEP “new category” from January to June 2018 and under “previously treated category” from January to March 2018. Quantitative data downloaded from Nikshay in Excel format was imported. Results: A total of 8301 patients with DS-TB registered under NTEP. Mean (standard deviation [SD]) age of DS-TB patients was 35.3 + 16.9 years, and 63.2% were in the age group of 15–44 years. Also, 60.1% were male, 2.5% were human immunodeficiency virus (HIV) positive, 65.3% were pulmonary TB cases, and 70.4% obtained treatment from public providers. Proportion of “successful” and “unsuccessful” outcomes was 87.9% and 12.1%, respectively, in the new treatment category and 78.3% and 21.7%, respectively, in the previously treated category. Among the patients classified under new category, the unsuccessful treatment outcome remained significantly high after adjustments with known confounders among patients aged 45–54 years (adjusted relative risks [aRR] 1.59, 95% confidence interval [CI] 1.31–1.93) and 55–64 years (aRR 1.67, 95% CI 1.36–2.05) compared to patients aged <15 years. Conclusion: Unsuccessful treatment outcome was significantly high among patients aged 45–54 years. Various adherence mechanisms implemented can be evaluated for further upscaling and improving the program effectiveness.

BackgroundInvestigating the safety and efficacy of single-inhaler triple therapy with glycopyrronium (GB) 12.5 μg/formoterol fumarate (FF) 12 μg/fluticasone propionate (FP) 250 μg, compared to GB 50 μg co-administered with a fixed dose of FF 12 μg/FP 250 μg in subjects with COPD.MethodsA phase 3, randomised, double-blind, active-control, parallel-group, noninferiority study conducted at 20 sites across India. COPD patients aged ≥40 to ≤75 years, with FEV1/FVC <0.70, using mono/dual therapy with ICS, LAMA, or LABA for ≥1 month, were included. Subjects were randomised 1:1 to GB/FF/FP or GB+FF/FP for 12 weeks. Primary efficacy endpoint was the change from baseline in trough FEV1 at the end of 12 weeks. The study is registered with the Clinical Trials Registry of India (CTRI Reg No: CTRI/2019/01/017156).ResultsBetween March 23, 2019 and February 14, 2020, 396 subjects were enrolled, 198 patients each in the fixed-triple (GB/FF/FP) and open-triple (GB+FF/FP) groups. The difference in LSM changes in predose FEV1 from baseline at 12 weeks was noninferior between the groups (p<0.05). The LSM change from baseline in postdose FEV1 was comparable (p=0.38). Superiority test showed comparable efficacy (p =0.12) for the difference in mean change from baseline in trough FEV1 between the groups. Adverse events (mild or moderate) were recorded in 25.3% and 24.9% of subjects in the GB/FF/FP and GB+FF/FP groups.ConclusionsFixed triple therapy with GB/FF/FP provides comparable bronchodilation and lung function improvement like open triple therapy. It is safe and well-tolerated in symptomatic COPD patients with a history of exacerbations.

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