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

• Status: Terminated
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborator: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
• Treatments: Anti-Inflammatory Agents; Simvastatin

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)