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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Centre hospitalier de l'Université de Montréal (CHUM).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01771198
First received: December 3, 2012
Last updated: January 16, 2013
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Rhinosinusitis
Drug: SIMVASTATIN
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preliminary Evaluation of SIMVASTATIN as an Alternative Anti-inflammatory Agent in Chronic Rhinosinusitis Refractory to Conventional Medical and Surgical Treatment

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Sino-Nasal symptomatology [ Time Frame: Between Day 30 and Day 60 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Bacterial culture [ Time Frame: Between Day 30 and Day 60 ] [ Designated as safety issue: No ]
  • Assessemt of liver and kidney functions [ Time Frame: Between Day 0 and Day 60 ] [ Designated as safety issue: Yes ]
    Alterations in hepatic and renal functions will be assessed at screening to exclude indivudals with pre-existing disturbances. These will be repated at day 60 of treatment to monitor potential treatment-related effects.

  • RNA measurement of inflammatory biomarkers [ Time Frame: Between Day 30 and Day 60 ] [ Designated as safety issue: No ]
    Total RNA will be extracted from sinus brushing samples.

  • Sinus-Specific Quality of Life (22 questions Sino-nasal outcome test; SNOT-22) [ Time Frame: At Day 0 and Day 30 compared to Day 60 and Day 90 ] [ Designated as safety issue: No ]
  • Aspect of sinus mucosa aspect assessed by sinus endoscopy [ Time Frame: At Day 0 and Day 30 compared to Day 60 and Day 90 ] [ Designated as safety issue: No ]
    Assessement of the inflammatory aspect of the sinus mucosa by direct endoscopy of the operated sinus cavities. Grading using the Lund-Kennedy grading system.


Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SIMVASTATIN 40mg
SIMVASTATIN tablet of 40mg once a day during 30 days. Single arm with pre and post treament assessment
Drug: SIMVASTATIN
SIMVASTATIN tablet of 40mg once a day during 30 days
Other Names:
  • ZOCOR (trade name)
  • pms-SIMVASTATIN

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771198

Contacts
Contact: Leandra Mfuna Endam, MSc 514-890-8000 ext 14170 leandra.mfuna-endam.chum@ssss.gouv.qc.ca
Contact: Martin Desrosiers, MD, FRCSC 514-890-8444 desrosiers_martin@hotmail.com

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM) Recruiting
Montreal, Quebec, Canada, H2W 1T8
Contact: Leandra Mfuna Endam, MSc    514-890-8000 ext 14170    leandra.mfuna-endam.chum@ssss.gouv.qc.ca   
Contact: Martin Desrosiers, MD, FRCSC    514-890-8444    desrosiers_martin@hotmail.com   
Principal Investigator: Martin Desrosiers, MD, FRCSC         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Investigators
Principal Investigator: Martin Desrosiers, MD, FRCSC Centre hospitalier de l'Université de Montréal (CHUM)
  More Information

Publications:
Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01771198     History of Changes
Other Study ID Numbers: CE11.288, Control Number: 156827
Study First Received: December 3, 2012
Last Updated: January 16, 2013
Health Authority: Canada: Health Canada

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Chronic rhinosinusitis
Refractory to treatment
SIMVASTATIN

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Simvastatin
Anti-Inflammatory Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014