Trial Outcomes & Findings for Comparing the Use of Saline or Saline Plus Gentamycin in Nasal Irrigation to Treat Chronic Sinusitis in Children (NCT NCT00465530)
NCT ID: NCT00465530
Last Updated: 2013-05-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Change from Baseline to 6 Weeks
Results posted on
2013-05-29
Participant Flow
Participant milestones
| Measure |
Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)
|
Saline (Once Daily, 40 mL to Each Nostril)
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
19
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing the Use of Saline or Saline Plus Gentamycin in Nasal Irrigation to Treat Chronic Sinusitis in Children
Baseline characteristics by cohort
| Measure |
Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)
n=21 Participants
|
Saline (Once Daily, 40 mL to Each Nostril)
n=19 Participants
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
19 participants
n=107 Participants
|
40 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 6 WeeksChange 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.
Outcome measures
| Measure |
Saline (Once Daily, 40 mL to Each Nostril)
n=15 Participants
|
Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)
n=19 Participants
|
|---|---|---|
|
Change in Computed Tomography (CT) Score After Treatment
Left maxillary
|
-.64 units on a scale
Standard Deviation .63
|
-.63 units on a scale
Standard Deviation .5
|
|
Change in Computed Tomography (CT) Score After Treatment
Right maxillary
|
-.5 units on a scale
Standard Deviation .65
|
-.5 units on a scale
Standard Deviation .63
|
|
Change in Computed Tomography (CT) Score After Treatment
Left anterior ethmoid
|
-.79 units on a scale
Standard Deviation .7
|
-1.06 units on a scale
Standard Deviation .68
|
|
Change in Computed Tomography (CT) Score After Treatment
Right anterior ethmoid
|
-.79 units on a scale
Standard Deviation .8
|
-.63 units on a scale
Standard Deviation .81
|
|
Change in Computed Tomography (CT) Score After Treatment
Left posterior ethmoid
|
-.57 units on a scale
Standard Deviation .65
|
-.81 units on a scale
Standard Deviation .66
|
|
Change in Computed Tomography (CT) Score After Treatment
Right posterior ethmoid
|
-.64 units on a scale
Standard Deviation .63
|
-.75 units on a scale
Standard Deviation .68
|
|
Change in Computed Tomography (CT) Score After Treatment
Left sphenoid
|
-.43 units on a scale
Standard Deviation .65
|
-.5 units on a scale
Standard Deviation .73
|
|
Change in Computed Tomography (CT) Score After Treatment
Right sphenoid
|
-.5 units on a scale
Standard Deviation .65
|
-.5 units on a scale
Standard Deviation .73
|
|
Change in Computed Tomography (CT) Score After Treatment
Left frontal
|
-.89 units on a scale
Standard Deviation .78
|
-.56 units on a scale
Standard Deviation .53
|
|
Change in Computed Tomography (CT) Score After Treatment
Right frontal
|
-.8 units on a scale
Standard Deviation .63
|
-.22 units on a scale
Standard Deviation .44
|
|
Change in Computed Tomography (CT) Score After Treatment
Left OMC
|
-1 units on a scale
Standard Deviation 1.03
|
-1.25 units on a scale
Standard Deviation 1
|
|
Change in Computed Tomography (CT) Score After Treatment
Right OMC
|
-.86 units on a scale
Standard Deviation 1.29
|
-.88 units on a scale
Standard Deviation 1.02
|
|
Change in Computed Tomography (CT) Score After Treatment
Total Score, left
|
-4.07 units on a scale
Standard Deviation 3.25
|
-4.56 units on a scale
Standard Deviation 2.42
|
|
Change in Computed Tomography (CT) Score After Treatment
Total score, right
|
-3.86 units on a scale
Standard Deviation 3.11
|
-3.38 units on a scale
Standard Deviation 2.66
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Saline (Once Daily, 40 mL to Each Nostril)
n=15 Participants
|
Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)
n=19 Participants
|
|---|---|---|
|
Change in Overall Quality of Life
|
.69 units on a scale
Standard Deviation 1.75
|
1.38 units on a scale
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: Baseline to 3 WeeksMeasured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.
Outcome measures
| Measure |
Saline (Once Daily, 40 mL to Each Nostril)
n=15 Participants
|
Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)
n=19 Participants
|
|---|---|---|
|
Change in Overall Quality of Life
|
2.53 units on a scale
Standard Deviation 1.99
|
2.06 units on a scale
Standard Deviation 2.88
|
Adverse Events
Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Saline (Once Daily, 40 mL to Each Nostril)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)
n=21 participants at risk
|
Saline (Once Daily, 40 mL to Each Nostril)
n=19 participants at risk
|
|---|---|---|
|
Ear and labyrinth disorders
Otalgia
|
0.00%
0/21
|
5.3%
1/19 • Number of events 3
|
|
General disorders
Symptoms of Allergic rhinitis
|
4.8%
1/21 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Acute otitis media (AOM)
|
0.00%
0/21
|
10.5%
2/19 • Number of events 2
|
|
Ear and labyrinth disorders
Epistaxis
|
4.8%
1/21 • Number of events 1
|
0.00%
0/19
|
|
General disorders
Cough
|
4.8%
1/21 • Number of events 1
|
0.00%
0/19
|
|
General disorders
Poison Ivy
|
0.00%
0/21
|
5.3%
1/19 • Number of events 1
|
|
Ear and labyrinth disorders
Auditory
|
0.00%
0/21
|
5.3%
1/19 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place