Health Condition 1: J849- Interstitial pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Group A Sequential immunosuppressive & antifibrotic
prednisolone plus MMF plus nintedanib: All medications will be administered orally.
Prednisolone plus Mycophenolate mofetil MMF for i
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of non IPF PPF and percentage predicted fvc equal to 2 or more than 40 percent but less than 90 percent or percentage predicted corrected for Hb CARBON MONOXIDE diffusing capacity or CO TRANSFER capacity DRCO EQUAL TO OR MORE THAN 25 PERCENT but less than 80 percent at the screening visit
Exclusion criteria
Exclusion criteria: IPF REFUSAL TO PARTICIPATE OBVIOUS ADDITIONAL LUNG DISEASE PF due to radiation sarcoidosis boop hiv viral hepatitis cancer clinically active infection pregnancy and lactation and any malignancy or cirrhosis or renal failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response (defined as decline in FVC is less than 5%)Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with a relative decline from baseline in FVC percentage predicted of equal to or more than 10 percentTimepoint: 6 months;Absolute change from baseline in K BILD total score and rate of exacerbation of ILD at the end of 6 monthsTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactVijay Hadda
All India Institute of Medical Sciences (AIIMS), New Delhi
Outcome results
None listed