Efficacy Study of SIMVASTATIN to Treat Chronic Rhinosinusitis After Failure of Optimal Treatment
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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
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Condition or disease | Intervention/treatment | Phase |
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Rhinosinusitis | Drug: SIMVASTATIN | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | August 2012 |
Actual Primary Completion Date : | July 2015 |
Actual Study Completion Date : | July 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: SIMVASTATIN 40mg
SIMVASTATIN tablet of 40mg once a day during 30 days. Single arm with pre and post treament assessment
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Drug: SIMVASTATIN
SIMVASTATIN tablet of 40mg once a day during 30 days
Other Names:
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- 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women aged between 18 and 65 years.
- Chronic rhinosinusitis with or without nasal polyposis requiring functional endoscopic surgery type of bilateral total ethmoidectomy older than six months
- Failure (clinical and endoscopic score > 1 on a scale of 3) of conventional treatment after surgery followed by local treatment with corticosteroids and saline irrigation)
Exclusion Criteria:
- Cystic Fibrosis
- Primary immunodeficiencies or documented acquired
- Diabetes
- Taking anticoagulants or bleeding disorders
- Taking oral cortisone within 30 days prior to the inclusion
- Taking antibiotics within 30 days prior to the inclusion
- Sinus or nasal surgery in past six months
- Contraindication to statins (pregnancy or lactating; people consuming high quantities of alcohol (3 drinks/day or more), liver disease, severe renal failure, myopathy, hypersensitivity to statins, abnormally elevated transaminase coagulation)

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
Canada, Quebec | |
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) |
Publications:
Responsible Party: | Centre hospitalier de l'Université de Montréal (CHUM) |
ClinicalTrials.gov Identifier: | NCT01771198 History of Changes |
Other Study ID Numbers: |
CE11.288 Control Number: 156827 ( Other Identifier: Health Canada ) |
First Posted: | January 18, 2013 Key Record Dates |
Last Update Posted: | July 13, 2015 |
Last Verified: | August 2012 |
Chronic rhinosinusitis Refractory to treatment SIMVASTATIN |
Simvastatin Sinusitis Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |