Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis - Full Text View

Sponsor:	Carmel Medical Center
Information provided by:	Carmel Medical Center
ClinicalTrials.gov Identifier:	NCT00335309

Purpose

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.

Condition	Intervention
Sinusitis	Procedure: Maxillary Sinus Irrigation Drug: IV Amoxicillin and Clavulanate acid

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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Sinusitis

Drug Information available for: Amoxicillin Amoxicillin sodium Clavulanic acid Amoxicillin trihydrate Amoxicillin-potassium clavulanate combination

U.S. FDA Resources

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:

CT Scoring [ Time Frame: on recruiting and follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life Questionaire [ Time Frame: on recruiting and follow-up ] [ Designated as safety issue: No ]
Nasal Endoscopy score [ Time Frame: upon recruiting and follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	October 2005
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Sinus Irrigation and IV antibiotics	Procedure: Maxillary Sinus Irrigation Once a day irrigation with 100cc saline for 5 days
2: Active Comparator IV antibiotics alone	Drug: IV Amoxicillin and Clavulanate acid IV Amoxycillin and Clavulanate 1 Gram TID for 5 days.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335309

Contacts

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

Locations

Israel
Carmel MC	Recruiting
Haifa, Israel, 34362
Principal Investigator: Ohad - Ronen, MD

Sponsors and Collaborators

Carmel Medical Center

Investigators

Principal Investigator:

Ohad Ronen, MD

ENT Department, Carmel Medical Center, Haifa

More Information

Publications:

Benninger MS, Sedory Holzer SE, Lau J. Diagnosis and treatment of uncomplicated acute bacterial rhinosinusitis: summary of the Agency for Health Care Policy and Research evidence-based report. Otolaryngol Head Neck Surg. 2000 Jan;122(1):1-7.

Gliklich RE, Metson R. The health impact of chronic sinusitis in patients seeking otolaryngologic care. Otolaryngol Head Neck Surg. 1995 Jul;113(1):104-9.

Benninger MS, Appelbaum PC, Denneny JC, Osguthorpe DJ, Stankiewicz JA. Maxillary sinus puncture and culture in the diagnosis of acute rhinosinusitis: the case for pursuing alternative culture methods. Otolaryngol Head Neck Surg. 2002 Jul;127(1):7-12.

Responsible Party:	Carmel Medical Center ( Ohad Ronen )
Study ID Numbers:	ENT-1/2005, 20051031
Study First Received:	June 8, 2006
Last Updated:	March 29, 2009
ClinicalTrials.gov Identifier:	NCT00335309 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Carmel Medical Center:

chronic rhinosinusitis
sinus irrigation

Additional relevant MeSH terms:

Anti-Infective Agents
Amoxicillin
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Paranasal Sinus Diseases
Clavulanic Acids
Enzyme Inhibitors
Sinusitis

Amoxicillin-Potassium Clavulanate Combination
Pharmacologic Actions
Nose Diseases
Anti-Bacterial Agents
Respiratory Tract Diseases
Respiratory Tract Infections
Clavulanic Acid
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2010