Efficacy Study of SIMVASTATIN to Treat Chronic Rhinosinusitis After Failure of Optimal Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01771198|
Recruitment Status : Terminated (Lack of efficacy with one month of treatement)
First Posted : January 18, 2013
Last Update Posted : July 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Rhinosinusitis||Drug: SIMVASTATIN||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preliminary Evaluation of SIMVASTATIN as an Alternative Anti-inflammatory Agent in Chronic Rhinosinusitis Refractory to Conventional Medical and Surgical Treatment|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
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
- Sino-Nasal symptomatology [ Time Frame: Between Day 30 and Day 60 ]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 ]
- Assessemt of liver and kidney functions [ Time Frame: Between Day 0 and Day 60 ]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 ]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 ]
- Aspect of sinus mucosa aspect assessed by sinus endoscopy [ Time Frame: At Day 0 and Day 30 compared to Day 60 and Day 90 ]Assessement of the inflammatory aspect of the sinus mucosa by direct endoscopy of the operated sinus cavities. Grading using the Lund-Kennedy grading system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)|