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Trial Outcomes & Findings for Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis (NCT NCT01197612)

NCT ID: NCT01197612

Last Updated: 2018-05-29

Results Overview

will be measured with the University of Pennsylvania Smell Identification Test (UPSIT), whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

23 participants

Primary outcome timeframe

3 weeks post-operation

Results posted on

2018-05-29

Participant Flow

Of 23 participants who consented, data is only available for 20. Two never had surgery, and so were not "assigned" at all.

Participant milestones

Participant milestones
Measure
Single Arm; Nostrils as Experimental and Comparator
each subject serves as their own control with one nostril being treated with pulmicort and one not pulmicort: applied to nasal packing after surgery
Overall Study
STARTED
18
Overall Study
Week 3
16
Overall Study
Returned for Week 24
6
Overall Study
COMPLETED
6
Overall Study
NOT COMPLETED
12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Single Arm; Nostrils as Experimental and Comparator
n=18 Participants
each subject serves as their own control with one nostril being treated with pulmicort and one not pulmicort: applied to nasal packing after surgery
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
18 Participants
n=99 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
Sex: Female, Male
Female
7 Participants
n=99 Participants
Sex: Female, Male
Male
11 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=99 Participants
Race (NIH/OMB)
White
17 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Region of Enrollment
United States
18 participants
n=99 Participants

PRIMARY outcome

Timeframe: 3 weeks post-operation

Population: Of sixteen participants at the three week mark, one participant's data was unable to be unblinded accurately, and one participant had no UPSIT scores taken, leaving an analysis population of 14,

will be measured with the University of Pennsylvania Smell Identification Test (UPSIT), whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification

Outcome measures

Outcome measures
Measure
Treated Nostril (Pulmicort)
n=14 Participants
each subject serves as their own control with one nostril being treated with pulmicort and one not pulmicort: applied to nasal packing after surgery
Untreated Nostril (no Pulmicort)
n=14 Participants
each subject serves as their own control with one nostril being treated with pulmicort and one not pulmicort: applied to nasal packing after surgery
Olfaction
20.2 units on a scale
Interval 8.0 to 36.0
19.8 units on a scale
Interval 6.0 to 37.0

SECONDARY outcome

Timeframe: 3 weeks post operation

Population: unblinding could not be done on one person accurately, so only 15 rather than 16 people's data could be analyzed

will be assessed with the Perioperative Sinus Endoscopy score (POSE), a 20 point scale where 0 is no sinus challenges and 20 represents the greatest blockage.

Outcome measures

Outcome measures
Measure
Treated Nostril (Pulmicort)
n=15 Participants
each subject serves as their own control with one nostril being treated with pulmicort and one not pulmicort: applied to nasal packing after surgery
Untreated Nostril (no Pulmicort)
n=15 Participants
each subject serves as their own control with one nostril being treated with pulmicort and one not pulmicort: applied to nasal packing after surgery
Sinonasal Health
4.5 units on a scale
Interval 1.0 to 10.0
4.7 units on a scale
Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 24 weeks post operation

Population: Of six participants remaining at 24 weeks, one participant's data could not be accurately unblinded leaving analysis of 5

Scored with the University of Pennsylvania Smell Identification Test, whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification

Outcome measures

Outcome measures
Measure
Treated Nostril (Pulmicort)
n=5 Participants
each subject serves as their own control with one nostril being treated with pulmicort and one not pulmicort: applied to nasal packing after surgery
Untreated Nostril (no Pulmicort)
n=5 Participants
each subject serves as their own control with one nostril being treated with pulmicort and one not pulmicort: applied to nasal packing after surgery
Olfaction
20.4 units on a scale
Interval 9.0 to 37.0
20 units on a scale
Interval 7.0 to 38.0

SECONDARY outcome

Timeframe: 24 weeks post operation

Population: Of six participants at 24 weeks, one's data was unable to be unblinded accurately, leaving an analysis population of 5 participants

Assessed with Perioperative Sinus Endoscopy (POSE) score

Outcome measures

Outcome measures
Measure
Treated Nostril (Pulmicort)
n=5 Participants
each subject serves as their own control with one nostril being treated with pulmicort and one not pulmicort: applied to nasal packing after surgery
Untreated Nostril (no Pulmicort)
n=5 Participants
each subject serves as their own control with one nostril being treated with pulmicort and one not pulmicort: applied to nasal packing after surgery
Sinonasal Health
5.6 units on a scale
Interval 0.0 to 11.0
5.6 units on a scale
Interval 2.0 to 11.0

Adverse Events

Single Arm; Nostrils as Experimental and Comparator

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

Garrett Griffin, MD

University of Michigan

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place