Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: Roflumilast: 500 mcg, oral, once daily for 6 months administered along with standard anti-tuberculosis treatment (ATT) as per NTEP guidelines
Control Intervention1: Placebo: Placebo Tab
Sponsors
Jayakumar
Eligibility
Inclusion criteria
Inclusion criteria: Newly diagnosed, drug-sensitive pulmonary TB Positive sputum smear or culture-confirmed TB No history of prior TB treatment Willing to provide informed consent
Exclusion criteria
Exclusion criteria: Multi-drug resistant (MDR) or extensively drug-resistant (XDR) TB Patients with Extra Pulmonary TB Severe hepatic or renal dysfunction Known allergy to phosphodiesterase-4 (PDE4) inhibitors Co-infection with HIV (unless stable on ART) Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to sputum culture conversion in pulmonary TB patients receiving adjunctive roflumilast therapy vs placebo.Timepoint: Day 0, Day 30, Day 60, Day 120, Day 150 and Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of AEs and SAEs attributed to roflumilastTimepoint: Continuous from Day 0 to Day 360 | — |
Countries
India
Contacts
Public ContactMeenakshi N
Chettinad School of Pharmaceutical Sciences, Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education, Kelambakkam - 603103, Tamil Nadu, India
Outcome results
None listed