Efficacy Study of SIMVASTATIN to Treat Chronic Rhinosinusitis After Failure of Optimal Treatment (NCT01771198) | Clinical Trial Compass
TerminatedPhase 2
Efficacy Study of SIMVASTATIN to Treat Chronic Rhinosinusitis After Failure of Optimal Treatment
Stopped: Lack of efficacy with one month of treatement
Canada7 participantsStarted 2012-08
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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)