Using Nintedanib to treat lung fibrosis in sarcoidosis patients
A Randomised Controlled Trial to Study the Efficacy and Safety of Nintedanib in Fibrotic Sarcoidosis
PHASE4 · Post Graduate Institute of Medical Education and Research, Chandigarh · NCT06479603
This study is testing if the medication nintedanib can help slow down lung fibrosis in patients with sarcoidosis who are already on standard treatment.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Sex | All |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh (other) |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Chandigarh) |
| Trial ID | NCT06479603 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of nintedanib, an antifibrotic medication, in patients with fibrotic sarcoidosis who are already receiving standard immunosuppressive therapy. The study is designed as an open-label, parallel group randomized controlled trial conducted at the Chest Clinic of PGIMER in Chandigarh. Participants will undergo various assessments, including lung function tests and imaging, to evaluate the impact of nintedanib on lung fibrosis and functional decline. The goal is to determine if nintedanib can slow the progression of lung fibrosis in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a diagnosis of pulmonary sarcoidosis exhibiting signs of lung fibrosis.
Not a fit: Patients without fibrotic changes in their lungs or those not on stable immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients with fibrotic sarcoidosis.
How similar studies have performed: Previous studies have shown positive results with nintedanib in other fibrotic lung diseases, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chandigarh
- Postgraduate Institute of Medical Education and Research — Chandigarh, India (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sarcoidosis, Pulmonary