SinusitisNCT00465530
Comparing the Use of Saline or Saline Plus Gentamycin in Nasal Irrigation to Treat Chronic Sinusitis in Children
A study testing Saline and Gentamycin in people with Sinusitis, run by Julie Wei, MD at 2 sites in United States.
Trial summary
Healthy children may develop symptoms of chronic sinusitis such as chronic cough, chronic runny nose, nasal congestion, even headaches. Such symptoms may persist long after the child gets over other symptoms of a cold and commonly result in the prescription of oral antibiotics. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Sinusitis
- What is being tested?
- Saline and Gentamycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children age 4-17
- History of "Recurrent" or "Chronic Sinusitis"
- Definition: History must include > 3 months of any or a combination of the following symptoms:
- Nasal congestion/nasal airway obstruction
- Rhinorrhea/Nasal discharge
- Persistent cough (daytime)
Show all 14Show fewer
- Postnasal drip
- Headache
- Facial pain
- Foul breath
- Intermittent fever
- Caregiver (proxy responsible) able to read and understand English
- Has had at least 3 courses or a total of 21 days of oral antibiotic therapy for above symptoms in the previous 3 months
- Child has a CT scan of the coronal sinus without contrast within two months prior to visit date, which demonstrates and opacification of a single or multiple, ipsilateral or bilateral sinuses.
Who cannot join
- Inability of caregiver to read and understand English
- Mental retardation, cognitive impairment, or developmental delay
- History of cystic fibrosis
- History of immotile cilia syndrome
- History of immune suppression/immune compromise
- CT scan within past 4 weeks available for review at time of clinic visit which is entirely negative for evidence of sinus disease plus complete absence of any of the above symptoms
Show all 11Show fewer
- History of endoscopic sinus surgery
- History of patient's inability to tolerate attempted nasal irrigation in the past 6 months
- History of recent use of gentamycin intranasal irrigation or saline irrigation within the past 3 months
- History of presence of nasal polyposis
- History of allergic reaction of any kind to intravenous gentamycin or aminoglycosides in past medical history (for treatment of any infections)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Kansas MedWest
Shawnee, Kansas, 66217
About this study
Official title: Safety and Efficacy of Once Daily Intranasal Gentamycin Irrigation Versus Saline in the Treatment of Pediatric Chronic Sinusitis
Healthy children may develop symptoms of chronic sinusitis such as chronic cough, chronic runny nose, nasal congestion, even headaches. Such symptoms may persist long after the child gets over other symptoms of a cold and commonly result in the prescription of oral antibiotics. The purpose of this study is to evaluate whether using saline alone or saline plus an antibiotic (gentamycin) to irrigate the nose directly once a day for 6 weeks is effective and safe for the treatment of the above named symptoms. Computerized axial tomography (CAT) scans and quality of life surveys will be used to compare the health of the sinuses before and after treatment, and scored to determine which of the two treatments, saline alone or saline with gentamycin, is more effective in the treatment of this condition. The study hypothesis is that intranasal saline irrigation will work as well as saline plus gentamycin, and that majority of the patients will experience significant improvement after a 6 week treatment period.
Read the detailed description
In the pediatric population, rhinosinusitis is a common concern resulting frequently in the frequent and unsuccessful prescription of systemic oral antibiotic therapy. Children typically experience an estimated 6-8 upper respiratory illnesses per year, usually viral, and only 13% are estimated to result in true sinusitis. True and chronic sinusitis, if not adequately treated, may result in long term symptoms including nasal airway obstruction, nasal congestion, persistent mucopurulent rhinorrhea, daytime and nocturnal cough, headaches, daytime fatigue, and even exacerbation or poor control of underlying asthma. A child's quality of life can be severely impacted as is their caretaker's due to days of missed school, frequency of doctor visits and courses of oral antibiotic therapy prescribed for the above mentioned symptoms, which ultimately result in the development of resistant organisms in addition to potential negative side effects associated with systemic oral antibiotic use.
Intranasal saline irrigation is underutilized in the pediatric population, most likely due to the presumption that children will not cooperate nor tolerate the act of irrigation. Saline irrigation of the nose is an inexpensive and generally well tolerated treatment with very little side effects or risks. Rigorous data regarding the efficacy of saline irrigation has become more available in this past decade, with most studies demonstrating a clear improvement in patient quality of life as measured by various study instruments or outcome surveys.
In our protocol, patients will be randomized to receive either saline alone or saline plus gentamycin in the solution form for nasal irrigation once daily for a six week treatment period. Weekly phone calls will be made to check for possible adverse events while patients are on treatment, and at the end of the treatment period another CAT scan will be performed to assess the status of the sinuses. Overall improvement will be determined based on the sinus status on the second CAT scan as well as the quality of life survey filled out by parents.
- Conditions
- Sinusitis
- Being tested
- Saline, Gentamycin
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Intranasal Saline
GentamycinDrug
Intranasal irrigation
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Saline plus Gentamycin Receives: Drug: Saline; Drug: Gentamycin |
| 1 | Placebo comparator | Saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Computed Tomography (CT) Score After Treatment
Change in CT score reflects the Lund-Mackay staging system. Each sinus is scored separately and scores are determined for the right and the left side. The lowest score of 0 represents no opacification in the sinus. A score of 1 represents a partial opacification. A score of 2 represents complete opacification.
Measured: Change from Baseline to 6 Weeks
Change in Overall Quality of Life
Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.
Measured: 3 Weeks to Follow-Up (7 Weeks)
Secondary outcomes (1)
Change in Overall Quality of Life
Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.
Measured: Baseline to 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Wei, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julie Wei, MD, University of Kansas Medical Center
- Investigators
- Julie L Wei, M.D., Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465530
- Sponsor's protocol ID
- 10553
- Status last verified
- Apr 2013
- First submitted
- 23 Apr 2007
- Last updated
- 29 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Once Daily Intranasal Gentamycin Irrigation Versus Saline in the Treatment of Pediatric Chronic Sinusitis
- ClinicalTrials.gov ID
- NCT00465530
- Acronym / sponsor ID
- 10553
- Conditions
- Sinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Julie Wei, MDUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 25 Apr 2007 (estimated)
- Results
- Posted 29 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Healthy children may develop symptoms of chronic sinusitis such as chronic cough, chronic runny nose, nasal congestion, even headaches. Such symptoms may persist long after the child gets over other symptoms of a cold and commonly result in the prescription of oral antibiotics. The purpose of this study is to evaluate whether using saline alone or saline plus an antibiotic (gentamycin) to irrigate the nose directly once a day for 6 weeks is effective and safe for the treatment of the above named symptoms. Computerized axial tomography (CAT) scans and quality of life surveys will be used to compare the health of the sinuses before and after treatment, and scored to determine which of the two treatments, saline alone or saline with gentamycin, is more effective in the treatment of this condition. The study hypothesis is that intranasal saline irrigation will work as well as saline plus gentamycin, and that majority of the patients will experience significant improvement after a 6 week treatment period.
Detailed description
In the pediatric population, rhinosinusitis is a common concern resulting frequently in the frequent and unsuccessful prescription of systemic oral antibiotic therapy. Children typically experience an estimated 6-8 upper respiratory illnesses per year, usually viral, and only 13% are estimated to result in true sinusitis. True and chronic sinusitis, if not adequately treated, may result in long term symptoms including nasal airway obstruction, nasal congestion, persistent mucopurulent rhinorrhea, daytime and nocturnal cough, headaches, daytime fatigue, and even exacerbation or poor control of underlying asthma. A child's quality of life can be severely impacted as is their caretaker's due to days of missed school, frequency of doctor visits and courses of oral antibiotic therapy prescribed for the above mentioned symptoms, which ultimately result in the development of resistant organisms in addition to potential negative side effects associated with systemic oral antibiotic use.
Intranasal saline irrigation is underutilized in the pediatric population, most likely due to the presumption that children will not cooperate nor tolerate the act of irrigation. Saline irrigation of the nose is an inexpensive and generally well tolerated treatment with very little side effects or risks. Rigorous data regarding the efficacy of saline irrigation has become more available in this past decade, with most studies demonstrating a clear improvement in patient quality of life as measured by various study instruments or outcome surveys.
In our protocol, patients will be randomized to receive either saline alone or saline plus gentamycin in the solution form for nasal irrigation once daily for a six week treatment period. Weekly phone calls will be made to check for possible adverse events while patients are on treatment, and at the end of the treatment period another CAT scan will be performed to assess the status of the sinuses. Overall improvement will be determined based on the sinus status on the second CAT scan as well as the quality of life survey filled out by parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: Saline, Drug: GentamycinSaline plus Gentamycin |
| 1 | Placebo comparator | Drug: SalineSaline |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Healthy children age 4-17
- History of "Recurrent" or "Chronic Sinusitis"
- Caregiver (proxy responsible) able to read and understand English
- Has had at least 3 courses or a total of 21 days of oral antibiotic therapy for above symptoms in the previous 3 months
- Child has a CT scan of the coronal sinus without contrast within two months prior to visit date, which demonstrates and opacification of a single or multiple, ipsilateral or bilateral sinuses.
Key exclusion criteria (11 listed)
- Inability of caregiver to read and understand English
- Mental retardation, cognitive impairment, or developmental delay
- History of cystic fibrosis
- History of immotile cilia syndrome
- History of immune suppression/immune compromise
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 |
|---|---|---|
| SalineIntranasal Saline | Drug | 1, 2 |
| GentamycinIntranasal irrigation | Drug | 2 |
Primary outcome
Change in Computed Tomography (CT) Score After Treatment
Time frame: Change from Baseline to 6 Weeks
Change in CT score reflects the Lund-Mackay staging system. Each sinus is scored separately and scores are determined for the right and the left side. The lowest score of 0 represents no opacification in the sinus. A score of 1 represents a partial opacification. A score of 2 represents complete opacification.
Change in Overall Quality of Life
Time frame: 3 Weeks to Follow-Up (7 Weeks)
Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.
1 secondary outcome
Change in Overall Quality of Life
Time frame: Baseline to 3 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Julie L Wei, M.D. principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline and Gentamycin in people with Sinusitis, run by Julie Wei, MD at 2 sites in United States.
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 14 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 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 29 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Computed Tomography (CT) Score After Treatment (time frame: Change from Baseline to 6 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2013.