Overview

Roflumilust in Chronic Rhinosinusitis With Nasal Polyposis.

Status:
Not yet recruiting
Trial end date:
2023-03-01
Target enrollment:
0
Participant gender:
All
Summary
The current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine after approval of the institutional review board and taking informed written consent from every patient before participation in the study. The patients of this study will be randomly and equally distributed among case and control groups to compare the effect of Roflumilust administration with the effect of systemic and local corticosteroids on patients with chronic rhinosinusitis with nasal polyposis
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Menoufia University
Treatments:
Prednisolone
Criteria
Inclusion Criteria:

- chronic rhinosinusitis with nasal polyposis,

- No history of systemic steroid administration over the last three months

Exclusion Criteria:

- History of previous nasal surgery,

- Underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune
diseases),

- Hypersensitivity to Roflumilust