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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Julie Wei, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00465530
First received: April 23, 2007
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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 Intervention
Sinusitis
Drug: Saline
Drug: Gentamycin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Once Daily Intranasal Gentamycin Irrigation Versus Saline in the Treatment of Pediatric Chronic Sinusitis

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Change in Computed Tomography (CT) Score After Treatment [ Time Frame: Change from Baseline to 6 Weeks ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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:
  • Change in Overall Quality of Life [ Time Frame: Baseline to 3 Weeks ] [ Designated as safety issue: No ]
    Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.


Enrollment: 40
Study Start Date: March 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
Saline plus Gentamycin
Drug: Saline
Intranasal Saline
Other Name: Saline
Drug: Gentamycin
Intranasal irrigation
Other Name: Gentamycin
Placebo Comparator: 1
Saline
Drug: Saline
Intranasal Saline
Other Name: Saline

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.

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465530

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
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
  More Information

No publications provided

Responsible Party: Julie Wei, MD, Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00465530     History of Changes
Other Study ID Numbers: 10553
Study First Received: April 23, 2007
Results First Received: December 11, 2012
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014