Roflumilust in Chronic Rhinosinusitis With Nasal Polyposis.

Study Overview
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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

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.

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

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Drug: Roflumilust
* Drug: Prednisolone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case Group<br>The case group will receive a 10 days course of Roflumilust in a dose of 500 mg once daily. | Drug: Roflumilust<br>* A selective phosphodiesterase 4 Inhibitor<br>|
| Active Comparator: Control group<br>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<br>* Systemic corticosteroid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Roflumilust, Chronic Sinusitis with nasal polyposis, Phosphodiesterase inhibitor