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

NCT05626387 | Unknown Phase 4

• 1 other identifier: MYCOHYPE
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

HP; interstitial lung disease; ILD; diffuse parenchymal lung disease

Outcome Measures

Primary Outcomes (1)

• Lung function (FVC) decline

  Annual rate of decline in forced vital capacity (FVC) assessed using spirometry assessed over 52 weeks

  52 weeks

Secondary Outcomes (8)

• FEV1 decline

  52 weeks

• Severity of breathlessness

  52 weeks

• Six-minute walk distance

  52 weeks

• Disease specific health status

  52 weeks

• Diffusion capacity

  52 weeks

Study Arms (2)

Prednisolone alone

ACTIVE COMPARATOR

Oral prednisolone will be administered over 52 weeks, according to following schedule 0.75 mg/kg x 2 weeks 0.5 mg/kg x 2 weeks 20 mg/day x 4 weeks 15 mg/day x 4 weeks 10 mg/day x 4 weeks 5 mg/day x 10 weeks 5 mg on alternate days x 26 weeks

Drug: Prednisolone

Mycophenolate mofetil plus prednisolone

EXPERIMENTAL

Oral prednisolone will be administered according to the schedule in the prednisolone alone arm. Mycophenolate mofetil will be administered starting from 2 weeks after randomization. It will be initiated at a dose of 500 mg twice daily and will be escalated to 1000 mg twice daily after two weeks.

Drug: Mycophenolate Mofetil plus prednisolone

Interventions

Mycophenolate Mofetil plus prednisolone DRUG

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.

Also known as: Intervention

Mycophenolate mofetil plus prednisolone

Prednisolone DRUG

Prednisolone is a glucocorticoid that suppresses inflammation by several mechanisms.

Also known as: Control

Prednisolone alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic; Lung Diseases, Interstitial

Interventions

Mycophenolic Acid; Prednisolone; Methods

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Investigative Techniques

Study Officials

• Sahajal Dhooria, MD, DM

  Postgraduate Institute of Medical Education and Research, Chandigarh, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sahajal Dhooria, MD, DM

CONTACT

+911722756827; sahajal@gmail.com

Ritesh Agarwal, MD, DM

CONTACT

+911722756825; agarwal.ritesh@outlook.in

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: November 23, 2022
• Primary Completion: September 23, 2025
• Study Completion: October 23, 2025
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the completion and publication of the study results
• Access Criteria: On a reasonable request

Locations

IN (1)