Roflumilust in Chronic Rhinosinusitis With Nasal Polyposis.
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Case Group The case group will receive a 10 days course of Roflumilust in a dose of 500 mg once daily. |
Drug: Roflumilust
A selective phosphodiesterase 4 Inhibitor
|
| Active Comparator: 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. |
Drug: Prednisolone
Systemic corticosteroid
|
Outcome Measures
Primary Outcome Measures
- Comparison between pretreatment and posttreatment SNOT-22 score in both groups [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 [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 [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 [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 [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 [Two weeks after start of treatment]
Case and control groups are compared regarding post-treatment serum periostin level in pg/ml
Secondary Outcome Measures
- Assessment of the side effects of Roflumilust [Two weeks after start of treatment]
The side effects of Roflumilust will be assessed among the case group
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Menoufia Faculty of Medicine | Shibīn Al Kawm | Menoufia | Egypt | 32511 |
Sponsors and Collaborators
- Menoufia University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 1/2022 ENT