Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05626387
Status:
RECRUITING
Last Update Posted:
2022-11-30
First Post:
2022-11-15
Brief Title:
An RCT of Mycophenolate Mofetil MMF in Fibrotic Hypersensitivity Pneumonitis
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PGIMER
Study Overview
Official Title:
Mycophenolate Mofetil and Prednisolone Versus Prednisolone Alone in Fibrotic Hypersensitivity Pneumonitis a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2022-11
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:
MYCOHYPE
Brief Summary:
To our knowledge there is no randomized controlled trial assessing the efficacy of mycophenolate mofetil MMF in the treatment of HP We aim to perform a randomized study to assess the efficacy and safety of a regimen consisting of MMF and prednisolone against a regimen consisting of prednisolone alone for treating fibrotic HP We hypothesize that the treatment of patients with fibrotic HP with MMF and prednisolone will be more effective and safer than treatment with prednisolone alone
Detailed Description:
Hypersensitivity pneumonitis HP is a complex immunologically-mediated interstitial lung disease ILD resulting from sensitization to an inhaled antigen It may be categorized into acute acutesubacute or chronic forms based on the duration of disease or evidence of chronicity on radiological or pathological findings Lately the American Thoracic Society ATS Guidelines 2020 has endorsed a new classification of HP into non-fibrotic and fibrotic types based on the absence or presence of signs of fibrosis on chest computed tomography CT or histology According to a survey study about three-fourths of respiratory physicians believe that fibrotic HP should be treated with glucocorticoids as the treatment of first choice which also reflects the practice in most centers worldwide However there is some evidence that glucocorticoids may not be effective in the long-term treatment of fibrotic HP Also glucocorticoids are associated with several adverse effects especially when used over a long duration Therefore most experts recommend that glucocorticoids should be tapered to the lowest possible dose after a trial of about three months in chronicfibrotic HP
Hypersensitivity pneumonitis is characterized by an exaggerated T cell-mediated immune inflammatory response T-lymphocytic alveolitis due to increased migration local proliferation and decreased programmed cell death of lymphocytes Mycophenolate mofetil MMF is an immunosuppressive drug that acts by inhibiting the proliferation of T-lymphocytes and suppressing the recruitment of lymphocytes and monocytes into the sites of inflammation Therefore MMF is likely to be effective in the treatment of HP There are only a few retrospective studies on the efficacy of MMF in the treatment of HP To our knowledge there is no randomized controlled trial assessing the efficacy of MMF in the treatment of HP
We aim to perform a randomized study to assess the efficacy and safety of a regimen consisting of MMF and prednisolone against a regimen consisting of prednisolone alone for treating fibrotic HP We hypothesize that the treatment of patients with fibrotic HP with MMF and prednisolone will be more effective and safer than treatment with prednisolone alone
Hypersensitivity pneumonitis is characterized by an exaggerated T cell-mediated immune inflammatory response T-lymphocytic alveolitis due to increased migration local proliferation and decreased programmed cell death of lymphocytes Mycophenolate mofetil MMF is an immunosuppressive drug that acts by inhibiting the proliferation of T-lymphocytes and suppressing the recruitment of lymphocytes and monocytes into the sites of inflammation Therefore MMF is likely to be effective in the treatment of HP There are only a few retrospective studies on the efficacy of MMF in the treatment of HP To our knowledge there is no randomized controlled trial assessing the efficacy of MMF in the treatment of HP
We aim to perform a randomized study to assess the efficacy and safety of a regimen consisting of MMF and prednisolone against a regimen consisting of prednisolone alone for treating fibrotic HP We hypothesize that the treatment of patients with fibrotic HP with MMF and prednisolone will be more effective and safer than treatment with prednisolone alone
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