RCT of Nintedanib in Fibrotic Sarcoidosis
NCT Number: NCT06479603
Acronym: NINSARC
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Sarcoidosis, Pulmonary
Interventions: DRUG: Nintedanib|DRUG: Standard of care
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-30
Completion Date: 2026-01-31
Locations: Postgraduate Institute of Medical Education and Research, Chandigarh, India

Summary:
Sarcoidosis is generally managed with outdoor immune modulatory drugs, most commonly oral steroids and at times drugs like methotrexate or azathioprine as a steroid sparing agent.

Around 15-20% of sarcoidosis patient develop fibrosis of the lung parenchyma. The effect of antifibrotics in such patients needs more studies. Nintedanib has been used with good results in patients with fibrosing interstitial lung disease like IPF, SSC- ILD, and other progressive fibrosing ILD. By using nintedanib in fibrotic sarcoidosis we may be able to limit the functional disability in these patients by slowing the rate of fibrosis and loss of lung function. The use of nintedanib if results in decrease in fibrosis and consequent decline in loss of lung function then it may be a safe and viable option for such patients.

We hypothesise that in patients with fibrotic sarcoidosis on standard of care anti-inflammatory therapy, nintedanib may help in reducing the rate of decline in lung function and progressive fibrosis. We aim to evaluate the efficacy and safety of nintedanib in subjects with fibrotic sarcoidosis

Primary Outcome Measures: The difference in the mean change in forced vital capacity (FVC) between the study groups, The FVC will be measured at baseline and 12 months using spirometry performed by an expert technician, 12 months
Secondary Outcome Measures: The difference in the mean change in forced expiratory volume in one sec (FEV1) between the study groups, The FEV1 will be measured at baseline and 12 months using spirometry performed by an expert technician, 12 months|The difference in the mean change in the 6-minute walk distance (6MWD) between the study groups at the end of 12 months, The 6MWD will be measured at baseline and 12 months using a 6MWT performed by an expert technician, 12 months|Change in the sarcoidosis-related quality-of-life, Change in the sarcoidosis-related quality-of-life will be assessed by the score on the King's Sarcoidosis Questionnaire, 12 months|The difference in the mean change in the diffusing capacity of lung for carbon mono oxide (DLCO) between the study groups, The DLCO will be measured at baseline and 12 months and performed by an expert technician, 12 months|Treatment-related adverse effects, Number of treatment-related adverse effects in each arm. The grading of adverse events according to the Common Terminology Criteria for Adverse Events version 5.0. These will include diarrhea, gastrointestinal disturbances, liver function test abnormalities, nausea, vomiting, and any other adverse effects reported by the study subject., 12 months