Phase 3
N=18
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
Chronic Sinusitis · Polyposis
Bottom Line
View on ClinicalTrials.gov: NCT01197612 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Olfaction — 20.2; 19.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pulmicort (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Olfaction |
20.4; 20 | — |
| SECONDARY Sinonasal Health |
5.6; 5.6 | — |
| SECONDARY Olfaction |
20.4; 20 | — |
| SECONDARY Sinonasal Health |
5.6; 5.6 | — |
Summary
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01197612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.