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Prednisolone Duration in Pulmonary Sarcoidosis
NCT06654934Phase 4
Key facts
- Status
- Not yet recruiting
- Start
- Nov 2024
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Post Graduate Institute of Medical Education and Research
- Modality
- Orthosteric Ligands
- Drugs
- prednisolone
- Conditions
- pulmonary sarcoidosis
01
Overview
Phase 4, randomised, open-label trial of prednisolone in pulmonary sarcoidosis (2 arms), sponsored by Post Graduate Institute of Medical Education and Research. Primary endpoint: Relapse or treatment failure at 12 months. Planned start Nov 2024; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Short duration
6-month prednisolone (shorter treatment)
Long duration
12-month prednisolone (longer treatment)
03
Who it enrols
Adult patients aged 18-65 with a diagnosis of pulmonary sarcoidosis requiring immunosuppressive treatment, excluding those with contraindications to prednisone or recent significant glucocorticoid use.
04
Endpoints
Primary
Relapse or treatment failure
Secondary
Treatment response
Sarcoidosis health related quality of life
Forced vital capacity
Adverse effects
Time to relapse or treatment failure
Sarcoidosis-associated fatigue
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