Ignite Creation Date:
2024-07-17 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479603
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
RCT of Nintedanib in Fibrotic Sarcoidosis
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
Post Graduate Institute of Medical Education and Research Chandigarh
Study Overview
Official Title:
A Randomised Controlled Trial to Study the Efficacy and Safety of Nintedanib in Fibrotic Sarcoidosis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NINSARC
Brief 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 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
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
Detailed Description:
Setting This prospective randomised controlled trial will be conducted in the Chest Clinic of the Department of Pulmonary Medicine PGIMER Chandigarh after approval from the ethics committee
Study design Open label parallel group randomized controlled trial Blinding This will be an open label trial Neither the subject nor the investigators will be blinded to the assigned group The individual administering the Kings Sarcoid Questionnaire KSQ will be blinded to the group allocation
Study participants Diagnosed cases of pulmonary sarcoidosis of fibrotic phenotype who are on stable immunosuppressive therapy would be enrolled after screening for inclusion and exclusion criteria Consecutive subjects with fibrotic sarcoidosis will be screened for this study The subjects will undergo the following investigations complete blood counts liver and kidney function tests and an electrocardiogram ECG in addition to a thin-section chest CT if a recent scan within 6 months of screening is unavailable or a positron emission tomography PET if indicated clinically spirometry and a six-minute walk test 6MWT A venous blood sample total of 10 mL will be collected in plain and EDTA vials and stored for cytokine analysis and other testing
Study design Open label parallel group randomized controlled trial Blinding This will be an open label trial Neither the subject nor the investigators will be blinded to the assigned group The individual administering the Kings Sarcoid Questionnaire KSQ will be blinded to the group allocation
Study participants Diagnosed cases of pulmonary sarcoidosis of fibrotic phenotype who are on stable immunosuppressive therapy would be enrolled after screening for inclusion and exclusion criteria Consecutive subjects with fibrotic sarcoidosis will be screened for this study The subjects will undergo the following investigations complete blood counts liver and kidney function tests and an electrocardiogram ECG in addition to a thin-section chest CT if a recent scan within 6 months of screening is unavailable or a positron emission tomography PET if indicated clinically spirometry and a six-minute walk test 6MWT A venous blood sample total of 10 mL will be collected in plain and EDTA vials and stored for cytokine analysis and other testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None