Roflumilust in Chronic Rhinosinusitis With Nasal Polyposis.

Chronic Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05369039
• Other study ID #: 1/2022 ENT
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2022
• Est. completion date: March 2023

Study information

• Verified date: May 2022
• Source: Menoufia University
• Contact: Ahmad M Hamdan, MD
• Phone: 00201008993175
• Email: Ahmed.Hamdan[@]med.menofia.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 be included in the study, patients should be more than 18 years old, have chronic rhinosinusitis with nasal polyposis, and have no history of systemic steroid administration over the last three months. History of previous nasal surgery, underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases), and hypersensitivity to Roflumilust were the exclusion criteria for this study.

Patients of the study will be randomly and equally distributed between case and control groups using block randomization methods using 4 blocks each comprising 4 patients with 6 patterns for every block one of which was selected randomly using random numbers generated by Excel program. The case group will receive a 10 days course of Roflumilust in a dose of 500 mg once daily. 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.

Assessment protocol:

Patients of the study will be assessed before and at the end of the treatment protocol with history taking to define the inclusion and exclusion criteria and to assess the burden of nasal symptoms using SNOT-22 scale. Endoscopic examination of the nasal cavity will be performed to confirm the presence of bilateral nasal polyposis and to assess the degree of nasal polyposis using the Lund Kennedy score. Serum IL17 and periostin will be assessed using ELISA technique before and after treatment to assess the anti-inflammatory effects of the drug.

Outcome measures:

Primary outcome measures will include a comparison between the pre and post treatment values of SNOT-22 and Lund Kennedy scores, serum IL17, and serum priostin in both case and control groups. Another outcome measure will be the comparison between the case and control groups regarding the posttreatment and posttreatment values of the previous indices. Secondary outcome measures will include an assessment of the side effects of Roflumilust among the case group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Sinusitis
• Nasal Polyps
• Sinusitis

Intervention

Drug:
• Roflumilust
A selective phosphodiesterase 4 Inhibitor
• Prednisolone
Systemic corticosteroid

Locations

Country	Name	City	State
Egypt	Menoufia Faculty of Medicine	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

References & 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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Assessment of the side effects of Roflumilust	The side effects of Roflumilust will be assessed among the case group	Two weeks after start of treatment