Roflumilust in Chronic Rhinosinusitis With Nasal Polyposis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Chronic Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The statistician will be blinded to the patient's group

Study Groups

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Case Group

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

Group Type EXPERIMENTAL

Roflumilust

Intervention Type DRUG

A selective phosphodiesterase 4 Inhibitor

Control group

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.

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

Systemic corticosteroid

Interventions

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Roflumilust

A selective phosphodiesterase 4 Inhibitor

Intervention Type DRUG

Prednisolone

Systemic corticosteroid

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No