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Clinical Trials in India / NCT05626387
Active, not recruiting Phase 4

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

NCT05626387 · tracked via the Priya Life Science India tracker
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Phase
Phase 4
Started
2022-11-23
Last updated
2026-06-03

Condition(s) studied

Hypersensitivity Pneumonitis

Investigational drug(s) / intervention(s)

Mycophenolate Mofetil plus prednisolonePrednisolone

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.

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Postgraduate Institute of Medical Education and Research Chandigarh Chandigarh
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

More Post Graduate Institute of Medical Education and Research, Chandigarh trials in India

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05626387 on ClinicalTrials.gov ↗ ← All trials in India