Efficacy Study of SIMVASTATIN to Treat Chronic Rhinosinusitis After Failure of Optimal Treatment

NCT01771198 | Terminated Phase 2

• 2 other identifiers: CE11.288Control Number: 156827
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinosinusitis

Keywords

Chronic rhinosinusitis; Refractory to treatment; SIMVASTATIN

Outcome Measures

Primary Outcomes (1)

• Sino-Nasal symptomatology

  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

  Between Day 30 and Day 60

Secondary Outcomes (5)

• Bacterial culture

  Between Day 30 and Day 60

• Assessemt of liver and kidney functions

  Between Day 0 and Day 60

• RNA measurement of inflammatory biomarkers

  Between Day 30 and Day 60

• Sinus-Specific Quality of Life (22 questions Sino-nasal outcome test; SNOT-22)

  At Day 0 and Day 30 compared to Day 60 and Day 90

• Aspect of sinus mucosa aspect assessed by sinus endoscopy

  At Day 0 and Day 30 compared to Day 60 and Day 90

Study Arms (1)

SIMVASTATIN 40mg

EXPERIMENTAL

SIMVASTATIN tablet of 40mg once a day during 30 days. Single arm with pre and post treament assessment

Drug: SIMVASTATIN

Interventions

SIMVASTATIN DRUG

SIMVASTATIN tablet of 40mg once a day during 30 days

Also known as: ZOCOR (trade name), pms-SIMVASTATIN

SIMVASTATIN 40mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Cystic Fibrosis
• Primary immunodeficiencies or documented acquired
• Diabetes
• Taking anticoagulants or bleeding disorders
• 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)

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2W 1T8, Canada

Location

Related Publications (6)

• 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.

  PMID: 21357906 BACKGROUND

• Rezaie-Majd A, Maca T, Bucek RA, Valent P, Muller 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. doi: 10.1161/01.atv.0000022694.16328.cc.

  PMID: 12117737 BACKGROUND

• 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. doi: 10.4049/jimmunol.172.5.2903.

  PMID: 14978092 BACKGROUND

• 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. doi: 10.1177/154405910608500608.

  PMID: 16723648 BACKGROUND

• 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.

  PMID: 21493317 BACKGROUND

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

  PMID: 7574265 BACKGROUND

MeSH Terms

Conditions

Rhinosinusitis

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Martin Desrosiers, MD, FRCSC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: January 18, 2013
• Study Start: August 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 13, 2015

Record last verified: 2012-08

Locations

CA (1)