Efficacy Study of SIMVASTATIN to Treat Chronic Rhinosinusitis After Failure of Optimal Treatment
Recruitment status was Recruiting
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|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||August 2013 (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
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01771198
|Contact: Leandra Mfuna Endam, MSc||514-890-8000 ext email@example.com|
|Contact: Martin Desrosiers, MD, FRCSCfirstname.lastname@example.org|
|Centre Hospitalier de l'Université de Montréal (CHUM)||Recruiting|
|Montreal, Quebec, Canada, H2W 1T8|
|Contact: Leandra Mfuna Endam, MSc 514-890-8000 ext 14170 email@example.com|
|Contact: Martin Desrosiers, MD, FRCSC 514-890-8444 firstname.lastname@example.org|
|Principal Investigator: Martin Desrosiers, MD, FRCSC|
|Principal Investigator:||Martin Desrosiers, MD, FRCSC||Centre hospitalier de l'Université de Montréal (CHUM)|