Efficacy Study of SIMVASTATIN to Treat Chronic Rhinosinusitis After Failure of Optimal Treatment
The purpose of this study is to investigate the clinical efficacy of oral treatment with a statin, SIMVASTATIN 40mg, in a target population of patients with severe chronic rhinosinusitis resistant to surgery followed by conventional medical and surgical treatment.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Preliminary Evaluation of SIMVASTATIN as an Alternative Anti-inflammatory Agent in Chronic Rhinosinusitis Refractory to Conventional Medical and Surgical Treatment|
- Sino-Nasal symptomatology [ Time Frame: Between Day 30 and Day 60 ] [ Designated as safety issue: No ]Day 0: Day of recruitment/screening; Day 30: Thirty days after recruitment, day of enrollment of subjects with normal hepatic and renal blood tests, and initiation of SIMVASTATIN 40mg once a day during 30 days; Day 60: Thirty days after Day 30, end of treatment administration; Day 90: Thirty days after Day 60, follow-up visit
- Bacterial culture [ Time Frame: Between Day 30 and Day 60 ] [ Designated as safety issue: No ]
- Assessemt of liver and kidney functions [ Time Frame: Between Day 0 and Day 60 ] [ Designated as safety issue: Yes ]Alterations in hepatic and renal functions will be assessed at screening to exclude indivudals with pre-existing disturbances. These will be repated at day 60 of treatment to monitor potential treatment-related effects.
- RNA measurement of inflammatory biomarkers [ Time Frame: Between Day 30 and Day 60 ] [ Designated as safety issue: No ]Total RNA will be extracted from sinus brushing samples.
- Sinus-Specific Quality of Life (22 questions Sino-nasal outcome test; SNOT-22) [ Time Frame: At Day 0 and Day 30 compared to Day 60 and Day 90 ] [ Designated as safety issue: No ]
- Aspect of sinus mucosa aspect assessed by sinus endoscopy [ Time Frame: At Day 0 and Day 30 compared to Day 60 and Day 90 ] [ Designated as safety issue: No ]Assessement of the inflammatory aspect of the sinus mucosa by direct endoscopy of the operated sinus cavities. Grading using the Lund-Kennedy grading system.
|Study Start Date:||August 2012|
|Study Completion Date:||July 2015|
|Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Experimental: SIMVASTATIN 40mg
SIMVASTATIN tablet of 40mg once a day during 30 days. Single arm with pre and post treament assessment
SIMVASTATIN tablet of 40mg once a day during 30 days
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01771198
|Centre Hospitalier de l'Université de Montréal (CHUM)|
|Montreal, Quebec, Canada, H2W 1T8|
|Principal Investigator:||Martin Desrosiers, MD, FRCSC||Centre hospitalier de l'Université de Montréal (CHUM)|