Rhinosinusitis | Efficacy Study of SIMVASTATIN to Treat Chronic Rhinosinusitis After Failure of Optimal Treatment
Rhinosinusitis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:SIMVASTATINSIMVASTATIN tablet of 40mg once a day during 30 days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
SIMVASTATIN 40mgSIMVASTATIN tablet of 40mg once a day during 30 days. Single arm with pre and post treament assessment
Start Date: August 2012
Completed Date: July 2015
Phase: Phase 2
Primary Outcome: Sino-Nasal symptomatology
Secondary Outcome: Bacterial culture
Study sponsors, principal investigator, and references
Principal Investigator: Martin Desrosiers, MD, FRCSC
Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Collaborator: Centre de Recherche du Centre Hospitalier de l'Université de Montréal
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.