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Roflumilust in Chronic Rhinosinusitis With Nasal Polyposis.

NCT05369039 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-05-11

No results posted yet for this study

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

Conditions

  • Chronic Sinusitis

Interventions

DRUG

Roflumilust

A selective phosphodiesterase 4 Inhibitor

DRUG

Prednisolone

Systemic corticosteroid

Sponsors & Collaborators

  • Menoufia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2023-03-31
Completion
2023-03-31
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05369039 on ClinicalTrials.gov