Overview

An RCT of Mycophenolate Mofetil (MMF) in Fibrotic Hypersensitivity Pneumonitis

Status:
Not yet recruiting

Trial end date:
2025-10-23

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Postgraduate Institute of Medical Education and Research

Treatments:

Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Mycophenolic Acid
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate

Criteria

Inclusion Criteria:

i. A diagnosis of fibrotic hypersensitivity pneumonitis according to the criteria proposed
in the American Thoracic Society Guideline 2020 ii. Screening FVC at least 40% of the
predicted value iii. Able to provide a written, informed consent for participation in the
trial

Exclusion Criteria:

i. Baseline FVC <40% predicted ii. Leucopenia (white blood cell count <4·0 × 10^9 per L),
significant thrombocytopenia (platelet count <100 × 10^9 per L), or clinically significant
anemia (hemoglobin <10 g/dL) iii. Baseline liver transaminases (alanine aminotransferase
and aspartate aminotransferase) or bilirubin more than 1·5 times the upper normal limit
(except in the case of Gilbert's syndrome) iv. Serum creatinine higher than 2.0 mg/dL v.
Uncontrolled congestive heart failure vi. Receipt of prednisolone (more than or equal to 10
mg/day, or equivalent), in the 4 weeks before randomization vii. Prior use of prednisolone
(more than or equal to 10 mg/day, or equivalent), MMF, azathioprine, cyclophosphamide,
cyclosporine or any other non-glucocorticoid immunosuppressant drug, or antifibrotic agents
for more than 12 weeks in the previous year viii. Active infection (lung or elsewhere)
whose management would be compromised by MMF or prednisolone ix. Other serious concomitant
medical illness (eg, cancer), chronic debilitating illness (other than chronic HP), or drug
abuse x. Pregnancy (documented by urine pregnancy test) or breastfeeding xi. Unwilling to
participate in the study