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ACTIVE NOT RECRUITING
NCT05626387
PHASE4

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

Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

View on ClinicalTrials.gov

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.

Official title: Mycophenolate Mofetil and Prednisolone Versus Prednisolone Alone in Fibrotic Hypersensitivity Pneumonitis: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2022-11-23

Completion Date

2026-10-23

Last Updated

2026-06-03

Healthy Volunteers

No

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.

Locations (9)

Postgraduate Institute of Medical Education and Research

Chandigarh, Chandigarh, India

Yashoda Hospitals Hyderabad

Hyderabad, India

Rajasthan Hospital Jaipur

Jaipur, India

AIIMS, Jodhpur

Jodhpur, India

Sanjay Gandhi Postgraduate Institute

Lucknow, India

AIIMS, New Delhi

New Delhi, India

Safdarjung Hospital Delhi

New Delhi, India

AIIMS, Rishikesh

Rishikesh, India

CMC Vellore

Vellore, India