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

Sponsor:

Collaborator:

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Information provided by (Responsible Party):

Centre hospitalier de l'Université de Montréal (CHUM)

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Rhinosinusitis	Drug: SIMVASTATIN	Phase 2

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Study Design

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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.

Eligibility Criteria

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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

Criteria

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)

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2W 1T8

Sponsors and Collaborators

Centre hospitalier de l'Université de Montréal (CHUM)

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Investigators

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Principal Investigator:	Martin Desrosiers, MD, FRCSC	Centre hospitalier de l'Université de Montréal (CHUM)

More Information

Publications:

Vaidyanathan S, Barnes M, Williamson P, Hopkinson P, Donnan PT, Lipworth B. Treatment of chronic rhinosinusitis with nasal polyposis with oral steroids followed by topical steroids: a randomized trial. Ann Intern Med. 2011 Mar 1;154(5):293-302. doi: 10.7326/0003-4819-154-5-201103010-00003.

Rezaie-Majd A, Maca T, Bucek RA, Valent P, Müller MR, Husslein P, Kashanipour A, Minar E, Baghestanian M. Simvastatin reduces expression of cytokines interleukin-6, interleukin-8, and monocyte chemoattractant protein-1 in circulating monocytes from hypercholesterolemic patients. Arterioscler Thromb Vasc Biol. 2002 Jul 1;22(7):1194-9.

McKay A, Leung BP, McInnes IB, Thomson NC, Liew FY. A novel anti-inflammatory role of simvastatin in a murine model of allergic asthma. J Immunol. 2004 Mar 1;172(5):2903-8.

Sakoda K, Yamamoto M, Negishi Y, Liao JK, Node K, Izumi Y. Simvastatin decreases IL-6 and IL-8 production in epithelial cells. J Dent Res. 2006 Jun;85(6):520-3.

Wang W, Le W, Ahuja R, Cho DY, Hwang PH, Upadhyay D. Inhibition of inflammatory mediators: role of statins in airway inflammation. Otolaryngol Head Neck Surg. 2011 Jun;144(6):982-7. doi: 10.1177/0194599811400367. Epub 2011 Apr 5.

Lund VJ, Kennedy DW. Quantification for staging sinusitis. The Staging and Therapy Group. Ann Otol Rhinol Laryngol Suppl. 1995 Oct;167:17-21.

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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

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):


Chronic rhinosinusitis Refractory to treatment SIMVASTATIN

Additional relevant MeSH terms:

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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

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