Roflumilust in Chronic Rhinosinusitis With Nasal Polyposis.

NCT05369039 | Unknown Phase 2 FDA Drug

• 1 other identifier: 1/2022 ENT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Roflumilust; Chronic Sinusitis with nasal polyposis; Phosphodiesterase inhibitor

Outcome Measures

Primary Outcomes (6)

• Comparison between pretreatment and posttreatment SNOT-22 score in both groups

  Post-treatment SNOT-22 scores will be compared with pretreatment scores in both groups

  2 weeks after start of treatment

• Comparison between pretreatment and posttreatment Lund Kennedy scores in both groups

  Post-treatment Lund Kennedy scores will be compared with pretreatment scores in both groups

  Two weeks after start of treatment

• Comparison between pretreatment and posttreatment Serum periostin levels in both groups

  Post-treatment Serum periostin level in pg/ml will be compared with pretreatment levels in both group

  Two weeks after start of treatment

• Comparison between case and control groups regarding SNOT 22 score

  Case and control groups are compared regarding post-treatment SNOT-22 score

  Two weeks after start of treatment

• Comparison between case and control groups regarding Lund Kennedy score

  Case and control groups are compared regarding post-treatment Lund Kennedy score

  Two weeks after start of treatment

• Comparison between case and control groups regarding serum periostin level

  Case and control groups are compared regarding post-treatment serum periostin level in pg/ml

  Two weeks after start of treatment

Secondary Outcomes (1)

• Assessment of the side effects of Roflumilust

  Two weeks after start of treatment

Study Arms (2)

Case Group

EXPERIMENTAL

The case group will receive a 10 days course of Roflumilust in a dose of 500 mg once daily.

Drug: Roflumilust

Control group

ACTIVE COMPARATOR

The Control group will receive a 10 days course of systemic steroids in the form of oral prednisolone in a dose of 40 mg per day.

Drug: Prednisolone

Interventions

Roflumilust DRUG

A selective phosphodiesterase 4 Inhibitor

Case Group

Prednisolone DRUG

Systemic corticosteroid

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic rhinosinusitis with nasal polyposis,
• No history of systemic steroid administration over the last three months

You may not qualify if:

• History of previous nasal surgery,
• Underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases),
• Hypersensitivity to Roflumilust

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia Faculty of Medicine

Shibīn al Kawm, Menoufia, 32511, Egypt

Location

Related Publications (5)

• Hulse KE, Stevens WW, Tan BK, Schleimer RP. Pathogenesis of nasal polyposis. Clin Exp Allergy. 2015 Feb;45(2):328-46. doi: 10.1111/cea.12472.

  PMID: 25482020 BACKGROUND

• Ryu G, Bae JS, Kim JH, Kim EH, Lyu L, Chung YJ, Mo JH. Role of IL-17A in Chronic Rhinosinusitis With Nasal Polyp. Allergy Asthma Immunol Res. 2020 May;12(3):507-522. doi: 10.4168/aair.2020.12.3.507.

  PMID: 32141263 BACKGROUND

• Maxfield AZ, Landegger LD, Brook CD, Lehmann AE, Campbell AP, Bergmark RW, Stankovic KM, Metson R. Periostin as a Biomarker for Nasal Polyps in Chronic Rhinosinusitis. Otolaryngol Head Neck Surg. 2018 Jan;158(1):181-186. doi: 10.1177/0194599817737967. Epub 2017 Oct 17.

  PMID: 29040053 BACKGROUND

• Janosova V, Calkovsky V, Pedan H, Behanova E, Hajtman A, Calkovska A. Phosphodiesterase 4 Inhibitors in Allergic Rhinitis/Rhinosinusitis. Front Pharmacol. 2020 Jul 22;11:1135. doi: 10.3389/fphar.2020.01135. eCollection 2020.

  PMID: 32792957 BACKGROUND

• Inagaki N, Miura T, Daikoku M, Nagai H, Koda A. Inhibitory effects of beta-adrenergic stimulants on increased vascular permeability caused by passive cutaneous anaphylaxis, allergic mediators, and mediator releasers in rats. Pharmacology. 1989;39(1):19-27. doi: 10.1159/000138567.

  PMID: 2479953 BACKGROUND

MeSH Terms

Interventions

Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Ahmad M Hamdan, MD

CONTACT

00201008993175; Ahmed.Hamdan@med.menofia.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be blinded to the patient's group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2022
• First Posted: May 11, 2022
• Study Start: June 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication of the study
• Access Criteria: After approval of the authors on request

Locations

EG (1)