RCT of Nintedanib in Fibrotic Sarcoidosis

Launched by POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH · Jun 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called nintedanib in patients who have fibrotic sarcoidosis, a condition where lung tissue becomes scarred and can lead to breathing difficulties. The researchers want to find out if nintedanib can help slow down lung function decline and reduce the progression of lung scarring in people already receiving standard treatments like steroids. About 15-20% of those with sarcoidosis may develop this fibrosis, and previous studies show that nintedanib has worked well for other similar lung diseases.

To participate in the trial, you need to be at least 18 years old and have a diagnosis of pulmonary sarcoidosis with signs of lung fibrosis on a CT scan. You should also be experiencing symptoms like breathlessness or a persistent cough, and have been on a stable dose of certain immune-modulating treatments for at least three months. If you join the trial, you'll be monitored closely to see how well the treatment works and to ensure your safety. It's important to note that if you have certain serious health conditions or are pregnant, you may not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age more than 18 years
• • Diagnosed with pulmonary sarcoidosis (clinico-radiologic presentation consistent with pulmonary sarcoidosis (with or without extrapulmonary involvement) along with presence of non-necrotising granulomatous inflammation in any of the involved organ/tissue and exclusion of a known cause for the granulomatous inflammation OR in the absence of demonstration of granulomatous inflammation in tissues, a diagnosis of fibrotic pulmonary sarcoidosis on a multidisciplinary discussion (enrolment of subjects meeting the latter criteria will be capped at 20% of the planned sample size)
• • Presence of signs of fibrosis on a computed tomography scan such as coarse reticulation, irregular lines, traction bronchiectasis, fibrotic masses, or honeycombing involving ≥20% of the lung fields on visual examination
• • Having symptoms of breathlessness grade 1 or more on the modified Medical Research Council (mMRC) scale or persistent cough for more than 3 months
• • Forced vital capacity (FVC) \<80% predicted value for the age and sex of the subject using the reference equations for our subjects OR an exertional desaturation of 4% or more on a six-minute walk test (6MWT)
• • Receiving stable immunomodulatory treatment which includes standard of care drugs such as glucocorticoids alone or in combination with methotrexate, azathioprine, or mycophenolate mofetil for more than 3 months in a stable dose
• Exclusion Criteria:
• • Known cardiopulmonary or other comorbid illness that can explain the subject's illness except group 3 pulmonary hypertension due to fibrotic pulmonary sarcoidosis
• • Hypersensitivity or contraindication to nintedanib (including high dose antiplatelets or anticoagulants, and bleeding diatheses)
• • Received an antifibrotic drug such as pirfenidone or nintedanib for ≥8 weeks in the past one year
• • Baseline deranged liver function (alanine aminotransferase and aspartate aminotransferase or bilirubin more than 1·5 times the upper normal limit \[except in the case of Gilbert's syndrome\])
• • Serum creatinine higher than 2.0 mg/dL
• • Uncontrolled congestive heart failure
• • Other serious concomitant medical illness (eg, cancer), chronic debilitating illness (other than chronic HP), or drug abuse
• • Pregnancy (documented by urine pregnancy test) or breastfeeding
• • Unwilling to participate in the study