Health Condition 1: null- Idiopathic Pulmonary Fibrosis (IPF)
Conditions
Interventions
Intervention1: Pirfenidone Tablets 200 mg: The initial dose for adults is 200 mg, three times a day (600 mg/day) ,after a meal.
The dose should be gradually increased to a maximum of 600 mg, three t
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Note: No Age limit is given in protocol. 1. Written, signed, dated and ethics committee approved data sharing consent obtained from patients before performing any procedures. 2. Patients diagnosed with IPF as per the ATS/ERS/JRS/ALAT criteria 2011guidelines: a. Exclusion of other known causes of interstitial lung disease (ILD) (e.g., domestic and occupational environmental exposures, connective tissue disease, and drug toxicity). b. The presence of a UIP pattern on high-resolution computed tomography (HRCT) in patients not subjected to surgical lung biopsy. c. Specific combinations of HRCT and surgical lung biopsy pattern in patients subjected to surgical lung biopsy.
Exclusion criteria
Exclusion criteria: 1.Patients who have received pirfenidone for more than one year before the start of the study. 2.Pregnant or lactating women. 3.Known allergy or hypersensitivity to Pirfenidone or any components of the medication 4.Concomitant use of fluvoxamine 5.Severe hepatic impairment or end stage liver disease 6.Severe renal impairment (CrCl less than 30 ml/min) or end stage renal disease requiring dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital Capacity (VC) and Forced Vital Capacity (FVC)Timepoint: At baseline and 3 monthly intervals. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional assessments such as Diffusion lung capacity of CO (DLCO)and 6 minute walk testTimepoint: At baseline and 48 weeks;Clinically significant changes in vital signs and laboratory parametersTimepoint: During study period;HRCTTimepoint: At Baseline and week 48;Incidence and nature of adverse eventsTimepoint: During study period;Incidence of drug related adverse events.Timepoint: During study period;SymptomsTimepoint: At each visit. | — |
Countries
India
Contacts
Public ContactMr Rahul Namjoshi
Cipla Ltd, Mumbai
Outcome results
None listed