NCT05369039 is a Phase 2 clinical trial of Roflumilust in Chronic Sinusitis, sponsored by Menoufia University.

Who is sponsoring NCT05369039?

NCT05369039 is sponsored by Menoufia University.

What drugs are being tested in NCT05369039?

Interventions in NCT05369039: Roflumilust, Prednisolone.

What condition does NCT05369039 study?

NCT05369039 studies Chronic Sinusitis.

Is NCT05369039 still recruiting?

NCT05369039 is currently status unknown. Last updated 5 May 2022.

Last reviewed 2022-05-05 · How we verify

NCT05369039

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Potential Therapeutic Effect of Roflumilust (a Selective Phosphodiesterase 4inhibitor) on Chronic Rhinosinusitis With Nasal Polyposis.

Status unknown Phase 2 Last updated 5 May 2022

What this trial tests

Phase 2 trial testing Roflumilust in Chronic Sinusitis in 60 participants. Status unknown.

Timeline

1 June 2022

Primary endpoint
1 March 2023

1 March 2023

Quick facts

Lead sponsor	Menoufia University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	1 June 2022
Primary completion	1 March 2023
Estimated completion	1 March 2023
Sites	1 location across Egypt

Drugs / interventions tested

Roflumilust — full drug profile →
Prednisolone — full drug profile →

Conditions studied

Chronic Sinusitis — all drugs for Chronic Sinusitis →

Sponsor

Menoufia University

Who can join

18 and older, any sex, with Chronic Sinusitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Comparison between pretreatment and posttreatment SNOT-22 score in both groups
Time frame: 2 weeks after start of treatment
Post-treatment SNOT-22 scores will be compared with pretreatment scores in both groups
Comparison between pretreatment and posttreatment Lund Kennedy scores in both groups
Time frame: Two weeks after start of treatment
Post-treatment Lund Kennedy scores will be compared with pretreatment scores in both groups
Comparison between pretreatment and posttreatment Serum periostin levels in both groups
Time frame: Two weeks after start of treatment
Post-treatment Serum periostin level in pg/ml will be compared with pretreatment levels in both group
Comparison between case and control groups regarding SNOT 22 score
Time frame: Two weeks after start of treatment
Case and control groups are compared regarding post-treatment SNOT-22 score
Comparison between case and control groups regarding Lund Kennedy score
Time frame: Two weeks after start of treatment
Case and control groups are compared regarding post-treatment Lund Kennedy score
Comparison between case and control groups regarding serum periostin level
Time frame: Two weeks after start of treatment
Case and control groups are compared regarding post-treatment serum periostin level in pg/ml

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05369039 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Menoufia University
Last refreshed: 5 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05369039.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing