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| Name | Class |
|---|---|
| American Rhinologic Society | OTHER |
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That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm; nostrils as experimental and comparator | Other | each subject serves as their own control with one nostril being treated with pulmicort and one not |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pulmicort | Drug | applied to nasal packing after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 weeks post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 weeks post operation |
| Olfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Garrett R Griffin, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48103 | United States |
Of 23 participants who consented, data is only available for 20. Two never had surgery, and so were not "assigned" at all.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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, | Posted | Mean | Full Range | units on a scale | 3 weeks post-operation |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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This was a pilot study with less enrollment than desired and poor rate of completion with only 5 participants completing the full 24 week trial. This study could be done on a larger/similar scale with some additional useful data obtained.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Garrett Griffin, MD | University of Michigan | ggriffin@mw-fp.com |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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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
| 24 weeks post operation |
| Sinonasal Health | Assessed with Perioperative Sinus Endoscopy (POSE) score | 24 weeks post operation |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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 |
|
|
| 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. | unblinding could not be done on one person accurately, so only 15 rather than 16 people's data could be analyzed | Posted | Mean | Full Range | units on a scale | 3 weeks post operation |
|
|
|
| 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 | Of six participants remaining at 24 weeks, one participant's data could not be accurately unblinded leaving analysis of 5 | Posted | Mean | Full Range | units on a scale | 24 weeks post operation |
|
|
|
| Secondary | Sinonasal Health | Assessed with Perioperative Sinus Endoscopy (POSE) score | Of six participants at 24 weeks, one's data was unable to be unblinded accurately, leaving an analysis population of 5 participants | Posted | Mean | Full Range | units on a scale | 24 weeks post operation |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |