SinusitisNCT00335309
Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis
A study testing Maxillary Sinus Irrigation and IV Amoxicillin and Clavulanate acid in people with Sinusitis, run by Ohad Ronen at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sinusitis
- What is being tested?
- Maxillary Sinus Irrigation and IV Amoxicillin and Clavulanate acid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2005to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A previous sinonasal surgery or craniofacial trauma
- Isolated frontal or sphenoidal sinusitis
- Immunosuppressed (diabetes, cancer, etc.)
- Craniofacial deformity
- Allergic fungal sinusitis
- Nasal polyposis
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Sinusitis
- Being tested
- Maxillary Sinus Irrigation, IV Amoxicillin and Clavulanate acid
- Keywords
- chronic rhinosinusitis, sinus irrigation
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary Sinus IrrigationProcedure or surgery
Twice a day irrigation with 100cc saline for 4 days
IV Amoxicillin and Clavulanate acidDrug
IV Amoxycillin and Clavulanate 1 Gram TID for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The Investigational arm is treated with sinus irrigation with normal saline 0.9% and intravenous antibiotics of Augmentin 1 gram 3 times a day for 4 days, and then per os (PO) Augmentin 875mg twice a day (BID) for another 10 days. The treatment is done while the patient is admitted to the otolaryngology - head and neck surgery department. Receives: Procedure: Maxillary Sinus Irrigation |
| 2 | Active comparator | The control arm is treated with the same intravenous antibiotics of Augmentin 1 gram 3 times a day for 4 days, and then per os (PO) Augmentin 875mg twice a day (BID) for another 10 days. There is no sinus irrigation with normal saline for this arm. The treatment is done while the patient is admitted to the otolaryngology - head and neck surgery department. Receives: Drug: IV Amoxicillin and Clavulanate acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT Scoring
Measured: on recruiting and follow-up
Secondary outcomes (2)
Quality of life Questionaire
Measured: on recruiting and follow-up
Nasal Endoscopy score
Measured: upon recruiting and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startOct 2005
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohad Ronen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ohad Ronen, Carmel Medical Center
- Investigators
- Ohad Ronen, MD, Principal investigator, ENT Department, Carmel Medical Center, Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335309
- Sponsor's protocol ID
- ENT-1/2005
- Other IDs
- 20051031
- Status last verified
- Oct 2013
- First submitted
- 8 Jun 2006
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/S0194-5998(00)70135-5.
PubMed 10629474Gliklich RE, Metson R. The health impact of chronic sinusitis in patients seeking otolaryngologic care. Otolaryngol Head Neck Surg. 1995 Jul;113(1):104-9. doi: 10.1016/S0194-59989570152-4.
PubMed 7603703Benninger 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. doi: 10.1067/mhn.2002.124847.
PubMed 12161724
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00335309
- Acronym / sponsor ID
- ENT-1/2005
- Conditions
- Sinusitis
- Keywords
- chronic rhinosinusitis, sinus irrigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ohad RonenUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Maxillary Sinus IrrigationThe Investigational arm is treated with sinus irrigation with normal saline 0.9% and intravenous antibiotics of Augmentin 1 gram 3 times a day for 4 days, and then per os (PO) Augmentin 875mg twice a day (BID) for another 10 days. The treatment is done while the patient is admitted to the otolaryngology - head and neck surgery department. |
| 2 | Active comparator | Drug: IV Amoxicillin and Clavulanate acidThe control arm is treated with the same intravenous antibiotics of Augmentin 1 gram 3 times a day for 4 days, and then per os (PO) Augmentin 875mg twice a day (BID) for another 10 days. There is no sinus irrigation with normal saline for this arm. The treatment is done while the patient is admitted to the otolaryngology - head and neck surgery department. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- A previous sinonasal surgery or craniofacial trauma
- Isolated frontal or sphenoidal sinusitis
- Immunosuppressed (diabetes, cancer, etc.)
- Craniofacial deformity
- Allergic fungal sinusitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maxillary Sinus IrrigationTwice a day irrigation with 100cc saline for 4 days | Procedure or surgery | 1 |
| IV Amoxicillin and Clavulanate acidIV Amoxycillin and Clavulanate 1 Gram TID for 4 days. | Drug | 2 |
Primary outcome
CT Scoring
Time frame: on recruiting and follow-up
2 secondary outcomes
Quality of life Questionaire
Time frame: on recruiting and follow-up
Nasal Endoscopy score
Time frame: upon recruiting and follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
- Background: PubMed 10629474Benninger 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. doi: 10.1016/S0194-5998(00)70135-5.
- Background: PubMed 7603703Gliklich RE, Metson R. The health impact of chronic sinusitis in patients seeking otolaryngologic care. Otolaryngol Head Neck Surg. 1995 Jul;113(1):104-9. doi: 10.1016/S0194-59989570152-4.
- Background: PubMed 12161724Benninger 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. doi: 10.1067/mhn.2002.124847.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ohad Ronen, MD principal investigator
ENT Department, Carmel Medical Center, Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary Sinus Irrigation and IV Amoxicillin and Clavulanate acid in people with Sinusitis, run by Ohad Ronen at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT Scoring (time frame: on recruiting and follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00335309, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2013.