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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Postgraduate Institute of Medical Education and Research
RECRUITING
Chandigarh
Contact Information
Primary
Sahajal Dhooria, MD, DM
sahajal@gmail.com
+911722756827
Backup
Ritesh Agarwal, MD, DM
agarwal.ritesh@outlook.in
+911722756825
Time Frame
Start Date: 2022-11-23
Estimated Completion Date: 2025-10-23
Participants
Target number of participants: 144
Treatments
Active_comparator: Prednisolone alone
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
Experimental: Mycophenolate mofetil plus prednisolone
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.
Sponsors
Leads: Post Graduate Institute of Medical Education and Research, Chandigarh

This content was sourced from clinicaltrials.gov

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