Testing Mycophenolate Mofetil for Fibrotic Hypersensitivity Pneumonitis

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

This study is testing whether adding mycophenolate mofetil to the usual treatment with prednisolone can help people with fibrotic hypersensitivity pneumonitis breathe better and feel improved.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Pgimer
• Drugs / interventions: cyclophosphamide
• Locations: 1 site (Chandigarh)
• Trial ID: NCT05626387 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of mycophenolate mofetil (MMF) combined with prednisolone compared to prednisolone alone in treating fibrotic hypersensitivity pneumonitis (HP). The study will involve patients diagnosed with fibrotic HP, assessing their lung function and response to treatment over a specified period. By utilizing a randomized controlled design, the trial seeks to provide robust evidence regarding the potential benefits of MMF in this patient population. The hypothesis is that the combination therapy will yield better outcomes than glucocorticoids alone.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with fibrotic hypersensitivity pneumonitis who have a forced vital capacity (FVC) of at least 40% of the predicted value.

Not a fit: Patients with severe lung impairment (FVC less than 40% predicted) or significant blood disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a more effective and safer option for patients suffering from fibrotic hypersensitivity pneumonitis.

How similar studies have performed: While there is limited research specifically on MMF for fibrotic HP, the approach of using immunosuppressive therapies in similar interstitial lung diseases has shown promise in other studies.

Eligibility 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

Where this trial is running

Chandigarh

• Postgraduate Institute of Medical Education and Research — Chandigarh, India (Recruiting)

Study contacts

• Principal investigator: Sahajal Dhooria, MD, DM — Postgraduate Institute of Medical Education and Research, Chandigarh, India
• Study coordinator: Sahajal Dhooria, MD, DM

Conditions Hypersensitivity Pneumonitis; HP; interstitial lung disease; ILD; diffuse parenchymal lung disease