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)
Lung function (FVC) decline — 52 weeks Annual rate of decline in forced vital capacity (FVC) assessed using spirometry assessed over 52 weeks
Trial sites (9)
Facility
City
Region
Status
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
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.
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