Comparing the Use of Saline or Saline Plus Gentamycin in Nasal Irrigation to Treat Chronic Sinusitis in Children

• Sponsor: Julie Wei, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT00465530
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Duration (Months): 36
• Patients Per Site: 20
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Sinusitis	Drug: Saline; Drug: Gentamycin	N/A

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

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Once Daily Intranasal Gentamycin Irrigation Versus Saline in the Treatment of Pediatric Chronic Sinusitis
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 2 Saline plus Gentamycin	Drug: Saline; Intranasal Saline; Drug: Gentamycin; Intranasal irrigation
Placebo Comparator: 1 Saline	Drug: Saline; Intranasal Saline

Outcome Measures

Primary Outcome Measures

1. Change in Computed Tomography (CT) Score After Treatment [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.

2. Change in Overall Quality of Life [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.

Secondary Outcome Measures

1. Change in Overall Quality of Life [Baseline to 3 Weeks]

   Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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)

• 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.

Exclusion Criteria:

• 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

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
2	University of Kansas MedWest	Shawnee	Kansas	United States	66217

Sponsors and Collaborators

• Julie Wei, MD

Investigators

• Principal Investigator: Julie L Wei, M.D., University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Julie Wei, MD, Associate Professor, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT00465530
• Other Study ID Numbers: 10553
• First Posted: Apr 25, 2007
• Last Update Posted: May 29, 2013
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Sinusitis; Gentamicins

Study Results

Participant Flow

Arm/Group Title	Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)	Saline (Once Daily, 40 mL to Each Nostril)
Arm/Group Description
Period Title: Overall Study
STARTED	21	19
COMPLETED	19	15
NOT COMPLETED	2	4

Baseline Characteristics

Arm/Group Title	Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)	Saline (Once Daily, 40 mL to Each Nostril)	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	21	19	40
Age (Count of Participants)
<=18 years	21 100%	19 100%	40 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	12 57.1%	3 15.8%	15 37.5%
Male	9 42.9%	16 84.2%	25 62.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 4.8%	0 0%	1 2.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 4.8%	0 0%	1 2.5%
White	17 81%	18 94.7%	35 87.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 9.5%	1 5.3%	3 7.5%
Region of Enrollment (participants) [Number]
United States	21 100%	19 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Change in Computed Tomography (CT) Score After Treatment
Description	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.
Time Frame	Change from Baseline to 6 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Saline (Once Daily, 40 mL to Each Nostril)	Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)
Arm/Group Description
Measure Participants	15	19
Left maxillary	-.64 (.63)	-.63 (.5)
Right maxillary	-.5 (.65)	-.5 (.63)
Left anterior ethmoid	-.79 (.7)	-1.06 (.68)
Right anterior ethmoid	-.79 (.8)	-.63 (.81)
Left posterior ethmoid	-.57 (.65)	-.81 (.66)
Right posterior ethmoid	-.64 (.63)	-.75 (.68)
Left sphenoid	-.43 (.65)	-.5 (.73)
Right sphenoid	-.5 (.65)	-.5 (.73)
Left frontal	-.89 (.78)	-.56 (.53)
Right frontal	-.8 (.63)	-.22 (.44)
Left OMC	-1 (1.03)	-1.25 (1)
Right OMC	-.86 (1.29)	-.88 (1.02)
Total Score, left	-4.07 (3.25)	-4.56 (2.42)
Total score, right	-3.86 (3.11)	-3.38 (2.66)

2. Secondary Outcome

Title	Change in Overall Quality of Life
Description	Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.
Time Frame	Baseline to 3 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Saline (Once Daily, 40 mL to Each Nostril)	Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)
Arm/Group Description
Measure Participants	15	19
Mean (Standard Deviation) [units on a scale]	2.53 (1.99)	2.06 (2.88)

3. Primary Outcome

Title	Change in Overall Quality of Life
Description	Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.
Time Frame	3 Weeks to Follow-Up (7 Weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Saline (Once Daily, 40 mL to Each Nostril)	Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)
Arm/Group Description
Measure Participants	15	19
Mean (Standard Deviation) [units on a scale]	.69 (1.75)	1.38 (1.75)

Adverse Events

Arm/Group Title	Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)		Saline (Once Daily, 40 mL to Each Nostril)
Arm/Group Description
All Cause Mortality
	Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)		Saline (Once Daily, 40 mL to Each Nostril)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)		Saline (Once Daily, 40 mL to Each Nostril)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)		Saline (Once Daily, 40 mL to Each Nostril)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/21 (14.3%)		6/19 (31.6%)
Ear and labyrinth disorders
Otalgia	0/21 (0%)	0	1/19 (5.3%)	3
Epistaxis	1/21 (4.8%)	1	0/19 (0%)	0
Auditory	0/21 (0%)	0	1/19 (5.3%)	1
General disorders
Symptoms of Allergic rhinitis	1/21 (4.8%)	1	1/19 (5.3%)	1
Acute otitis media (AOM)	0/21 (0%)	0	2/19 (10.5%)	2
Cough	1/21 (4.8%)	1	0/19 (0%)	0
Poison Ivy	0/21 (0%)	0	1/19 (5.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.