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

NCT00465530 | Completed Results DMC

• 1 other identifier: 10553
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 Weeks to Follow-Up (7 Weeks)

Secondary Outcomes (1)

• Change in Overall Quality of Life

  Baseline to 3 Weeks

Study Arms (2)

2

EXPERIMENTAL

Saline plus Gentamycin

Drug: Saline; Drug: Gentamycin

1

PLACEBO COMPARATOR

Saline

Drug: Saline

Interventions

Saline DRUG

Intranasal Saline

1; 2

Gentamycin DRUG

Intranasal irrigation

2

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Julie Wei, MD: lead

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas MedWest

Shawnee, Kansas, 66217, United States

Location

MeSH Terms

Conditions

Sinusitis

Interventions

Sodium Chloride; Gentamicins

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Dr. Julie Wei
• Organization: University of Kansas Medical Center

jwei@kumc.edu

(913) 588-6664

Study Officials

• Julie L Wei, M.D.

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 25, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 29, 2013
• Results First Posted: May 29, 2013

Record last verified: 2013-04

Locations

US (2)