Nasal Polyps
Conditions
Keywords
Treatment
Brief summary
The purpose of this study is to compare the effectiveness of intranasal Triamcinolone delivered through a bio-absorbable nasal dressing verses oral steroids and a saline soaked dressing, in the treatment and prevention of early nasal polyposis.
Detailed description
nasopore, a bio-absorbable nasal dressing, may offer an alternative route of sustained steroid drug delivery. The use of topical targeted intranasal steroids may prevent the routine adverse effects of oral steroids while maintaining the same therapeutic / clinical efficacy.
Interventions
DRUGTriamcinolone
Triamcinolone soaked nasopore dressing
DRUGSaline soaked sponge
saline soaked sponge
Sponsors
Steward St. Elizabeth's Medical Center of Boston, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized into 2 study groups, experimental and control.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Patients with early nasal polyposis
Exclusion criteria
* Age \< 18 years * Patients with active sinus infections * Patients on long term steroids * Allergy or sensitivity to steroids * Patients with Antrochoanal polyps * Patients who received topical steroids by bio-resorbable sponge or oral steroids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Endoscopic Exam Findings . | 2 weeks, 6 weeks, 12 weeks were not collected from any participant. | nasal endoscopic exam findings at 2 weeks, 6 weeks and 12 weeks were not collected from any participant. |
Countries
United States
Participant flow
Pre-assignment details
One subject enrolled but study was terminated and subject did not start the study.
Participants by arm
| Arm | Count |
|---|---|
| Triamcinolone Nasopore Triamcinolone soaked sponge | 0 |
| Control Saline Soaked sponge | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Nasal Endoscopic Exam Findings .
nasal endoscopic exam findings at 2 weeks, 6 weeks and 12 weeks were not collected from any participant.
Time frame: 2 weeks, 6 weeks, 12 weeks were not collected from any participant.
Population: No participant started because study was terminated.