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

NCT05626387 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2022-11-30

No results posted yet for this study

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.

Conditions

  • Hypersensitivity Pneumonitis

Interventions

DRUG

Mycophenolate Mofetil plus prednisolone

Prednisolone is a glucocorticoid that suppresses inflammation by several mechanisms. 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.

DRUG

Prednisolone

Prednisolone is a glucocorticoid that suppresses inflammation by several mechanisms.

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Sahajal Dhooria, MD, DM · Postgraduate Institute of Medical Education and Research, Chandigarh, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-23
Primary Completion
2025-09-23
Completion
2025-10-23

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05626387 on ClinicalTrials.gov