Actively Recruiting
RCT of Nintedanib in Fibrotic Sarcoidosis
Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2024-10-23
120
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 it may be possible 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. The hypothesis of this study is 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. The aim is to evaluate the efficacy and safety of nintedanib in subjects with fibrotic sarcoidosis
CONDITIONS
Official Title
RCT of Nintedanib in Fibrotic Sarcoidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age more than 18 years
- Diagnosed with pulmonary sarcoidosis confirmed by clinical, radiologic, and tissue evidence or multidisciplinary discussion
- Signs of lung fibrosis involving 20% or more of lung fields on CT scan
- Breathlessness grade 1 or higher on the modified Medical Research Council scale or persistent cough for over 3 months
- Forced vital capacity less than 80% predicted for age and sex or oxygen desaturation of 4% or more on six-minute walk test
- Receiving stable immunosuppressive treatment including glucocorticoids alone or with methotrexate, azathioprine, or mycophenolate mofetil for over 3 months at a stable dose
You will not qualify if you...
- Known heart, lung, or other illnesses explaining symptoms except certain pulmonary hypertension
- Allergy or contraindication to nintedanib including bleeding risks
- Use of antifibrotic drugs like pirfenidone or nintedanib for 8 weeks or more in the past year
- Abnormal liver function tests above 1.75 times normal except Gilbert's syndrome
- Serum creatinine above 2.0 mg/dL
- Uncontrolled congestive heart failure
- Serious other illnesses such as cancer or drug abuse
- Pregnancy or breastfeeding
- Unwillingness to participate in the study
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Trial Site Locations
Total: 1 location
1
Postgraduate Institute of Medical Education and Research
Chandigarh, India
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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