CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Saline +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00465530
NCT00465530N/ACompleted

Safety and Efficacy of Once Daily Intranasal Gentamycin Irrigation Versus Saline in the Treatment of Pediatric Chronic Sinusitis

Julie Wei, MD·interventional·Posted Apr 25, 2007·Updated May 29, 2013

In Brief

A clinical study evaluating Saline and Gentamycin for Sinusitis. Completed, enrolled 40 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSinusitis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 25, 2007
Enrollment StartMar 1, 2007
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 19.2 years ago

Interventions

Salinedrug

Intranasal Saline

Gentamycindrug

Intranasal irrigation