Official Title: “Effectiveness of Maxillary Sinus Saline Irrigation in Conjunction With Systemic Antibiotic Therapy Versus Systemic Antibiotic Therapy Alone in the Management of Chronic Rhinosinusitis, a Prospective Randomized Controlled Trial”

The purpose of this study is to evaluate the effectiveness of maxillary sinus saline irrigation in conjunction with systemic antibiotic therapy versus systemic antibiotic therapy alone in the management of chronic rhinosinusitis, a prospective randomized controlled trial.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2010

Effectiveness of maxillary sinus saline irrigation in conjunction with systemic antibiotic therapy versus systemic antibiotic therapy alone in the management of chronic rhinosinusitis.

A prospective randomized controlled trial is being conducted in Carmel Medical Center, Haifa, Israel. Patients are being randomized into one of two arms. One arm receives sinus irrigation with saline in conjunction with IV antibiotics, the control arm receives the same regimen of IV antibiotics without the sinus irrigation. Quality of life, CT scans and nasal endoscopy parameters are collected before and after treatment.

Intervention(s) in this Clinical Trial

• Procedure: Maxillary Sinus Irrigation
  • Once a day irrigation with 100cc saline for 5 days
• Drug: IV Amoxicillin and Clavulanate acid
  • IV Amoxycillin and Clavulanate 1 Gram TID for 5 days.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Sinus Irrigation and IV antibiotics
• Active Comparator: 2
  • IV antibiotics alone

Primary Measures

• CT Scoring
  • Time Frame: on recruiting and follow-up
    Safety Issue?: No

Secondary Measures

• Quality of life Questionaire
  • Time Frame: on recruiting and follow-up
    Safety Issue?: No
• Nasal Endoscopy score
  • Time Frame: upon recruiting and follow-up
    Safety Issue?: No

Inclusion Criteria:

• Chronic (over 3 months) maxillary and ethmoidal rhinosinusitis (verified by a CT scan)
• Over 18 years of age
• Signed informed consent
• Not participating in another clinical study

Exclusion criteria:

• A previous sinonasal surgery or craniofacial trauma
• Isolated frontal or sphenoidal sinusitis
• Immunosuppressed (diabetes, cancer, etc.)
• Craniofacial deformity
• Allergic fungal sinusitis
• Nasal polyposis
• Rhinosinusitis of dental origin
• Bleeding tendency (e.g., chronic coumadin treatment)
• Patients participating in other clinical study
• Patients with penicillin allergy
• Patients with Augmentin resistant bacteria in cultures

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Carmel Medical Center

Overall Clinical Trial Officials and Contacts

Ohad Ronen, MD Principal Investigator ENT Department, Carmel Medical Center, Haifa  

Overall Contact: Ohad Ronen, MD 972-4-8250279 ohadro@clalit.org.il

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00335309

Study ID Number: ENT-1/2005

ClinicalTrials.gov Identifier: NCT00335309

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration