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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?

Rhinosinusitis

Study Interventions

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

Study Arms

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

Study Status

Terminated

Start Date: August 2012

Completed Date: July 2015

Phase: Phase 2

Type: Interventional

Design:

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

More information:https://clinicaltrials.gov/show/NCT01771198

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.

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