Trial Outcomes & Findings for Distribution of Topical Nasal Medication Within the Nasal Cavity and Sinuses by Radiographic Comparison (NCT NCT00626366)
NCT ID: NCT00626366
Last Updated: 2023-09-28
Results Overview
CT scan scored for distribution contrast delivered by nasal spray or drops within subsets in the nasal cavity. The sinonasal cavity was divided into twenty-one subsites on each side of the nasal cavity. The interpreters scored for the presence (1) or absence (0) of contrast from the nasal spray or nasal drops within each subsite. Left and right sides were interpreted separately for a possible total score of 0-42 for each CT scan.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
2 months
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
Nasal Spray
This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.
Sinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses
Omnipaque 240 Contrast Solution: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.
|
Nasal Drops
This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.
Sinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses
Omnipaque 240 mg I/mL: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Nasal Spray
n=9 Participants
This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.
Sinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses
Omnipaque 240 Contrast Solution: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.
|
Nasal Drops
n=9 Participants
This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.
Sinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses
Omnipaque 240 mg I/mL: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
18 Participants
n=18 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Age, Continuous
|
28.6 years
n=9 Participants
|
28.6 years
n=9 Participants
|
28.6 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
14 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=18 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
9 participants
n=9 Participants
|
18 participants
n=18 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: Each participant's CT scan will be scored for left and right sides for a total of 18 sinonasal cavities
CT scan scored for distribution contrast delivered by nasal spray or drops within subsets in the nasal cavity. The sinonasal cavity was divided into twenty-one subsites on each side of the nasal cavity. The interpreters scored for the presence (1) or absence (0) of contrast from the nasal spray or nasal drops within each subsite. Left and right sides were interpreted separately for a possible total score of 0-42 for each CT scan.
Outcome measures
| Measure |
Nasal Spray
n=18 nasal cavities (right and left sides)
This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses.
Sinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses
Omnipaque 240 Contrast Solution: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml.
|
Nasal Drops
n=18 nasal cavities (right and left sides)
This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.
Sinus CT Scan: Subjects will undergo a Xoran miniCAT scan of their sinuses
Omnipaque 240 mg I/mL: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.
|
|---|---|---|
|
To Measure the Distribution of Nasal Sprays and Drops.
Nasal vestibule
|
18 nasal cavities (right and left sides)
|
17 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Inferior upper nasal vault
|
16 nasal cavities (right and left sides)
|
17 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Anterior inferior meatus
|
16 nasal cavities (right and left sides)
|
0 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Anterior inferior nasal cavity
|
15 nasal cavities (right and left sides)
|
6 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Posterior inferior nasal cavity
|
3 nasal cavities (right and left sides)
|
1 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Anterior middle nasal cavity
|
3 nasal cavities (right and left sides)
|
5 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Posterior middle nasal cavity
|
2 nasal cavities (right and left sides)
|
4 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Anterior middle meatus
|
4 nasal cavities (right and left sides)
|
2 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Posterior ethmoid
|
1 nasal cavities (right and left sides)
|
2 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Frontal recess
|
0 nasal cavities (right and left sides)
|
2 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Sphenoethmoid recess
|
2 nasal cavities (right and left sides)
|
4 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Nasopharynx
|
8 nasal cavities (right and left sides)
|
2 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Superior upper nasal vault
|
0 nasal cavities (right and left sides)
|
6 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Anterior floor of nose
|
12 nasal cavities (right and left sides)
|
4 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Posterior floor of nose
|
9 nasal cavities (right and left sides)
|
0 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Posterior inferior meatus
|
9 nasal cavities (right and left sides)
|
1 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Anterior olfactory cleft
|
1 nasal cavities (right and left sides)
|
4 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Posterior olfactory cleft
|
1 nasal cavities (right and left sides)
|
4 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Anterior ethmoid
|
2 nasal cavities (right and left sides)
|
1 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Osteomeatal complex
|
2 nasal cavities (right and left sides)
|
1 nasal cavities (right and left sides)
|
|
To Measure the Distribution of Nasal Sprays and Drops.
Posterior middle meatus
|
2 nasal cavities (right and left sides)
|
1 nasal cavities (right and left sides)
|
Adverse Events
Nasal Spray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nasal Drop
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place