Chronic Sinusitis, Polyposis
Conditions
Brief summary
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.
Interventions
DRUGpulmicort
applied to nasal packing after surgery
Sponsors
American Rhinologic Society
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* hyposmia and nasal obstruction for \>12 weeks * bilateral nasal polyposis * candidate for surgery
Exclusion criteria
* immunocompromised * non-English speaking * prisoner * pregnant/lactating * will not attend follow up appointments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Olfaction | 3 weeks post-operation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sinonasal Health | 3 weeks post operation | 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. |
| Olfaction | 24 weeks post operation | 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 |
Countries
United States
Participant flow
Pre-assignment details
Of 23 participants who consented, data is only available for 20. Two never had surgery, and so were not assigned at all.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Single Arm; Nostrils as Experimental and Comparator |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Olfaction
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
Time frame: 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,
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treated Nostril (Pulmicort) | Olfaction | 20.2 units on a scale |
| Untreated Nostril (no Pulmicort) | Olfaction | 19.8 units on a scale |
Secondary
Olfaction
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
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treated Nostril (Pulmicort) | Olfaction | 20.4 units on a scale |
| Untreated Nostril (no Pulmicort) | Olfaction | 20 units on a scale |
Secondary
Sinonasal Health
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.
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treated Nostril (Pulmicort) | Sinonasal Health | 4.5 units on a scale |
| Untreated Nostril (no Pulmicort) | Sinonasal Health | 4.7 units on a scale |
Secondary
Sinonasal Health
Assessed with Perioperative Sinus Endoscopy (POSE) score
Time frame: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treated Nostril (Pulmicort) | Sinonasal Health | 5.6 units on a scale |
| Untreated Nostril (no Pulmicort) | Sinonasal Health | 5.6 units on a scale |