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Roflumilast for Exacerbation Prevention in Fibrotic Sarcoidosis
NCT01830959Phase 4
Key facts
- Status
- Unknown
- Start
- Apr 2013
- Primary completion
- May 2016
- Countries
- 1
- Sponsor
- University of Cincinnati
- Modality
- Small Molecules
- Drugs
- roflumilast
- Conditions
- sarcoidosis
01
Overview
Phase 4, randomised, double-blind trial in sarcoidosis comparing Roflumilast with Placebo (2 arms). Primary endpoint: Reduction in number of episodes of acute exacerbation at 1 year. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Roflumilast
Roflumilast 500 mcg/day added to standard of care
Placebo
Placebo added to standard of care
03
Who it enrols
Patients with fibrotic sarcoidosis, FEV1/FVC < 80%, and at least two exacerbations in the prior year.
04
Endpoints
Primary
Reduction in number of episodes of acute exacerbation
Secondary
Change in FVC
Changes in quality of life
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