Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
Overview[ - collapse ][ - ]
| Purpose | That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery. |
|---|---|
| Condition | Chronic Sinusitis Polyposis |
| Intervention | Drug: pulmicort |
| Phase | Phase 3 |
| Sponsor | University of Michigan |
| Responsible Party | University of Michigan |
| ClinicalTrials.gov Identifier | NCT01197612 |
| First Received | August 30, 2010 |
| Last Updated | September 8, 2010 |
| Last verified | August 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 30, 2010 |
|---|---|
| Last Updated Date | September 8, 2010 |
| Start Date | September 2010 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | olfaction [Time Frame: 3 weeks post-op] [Designated as safety issue: No]will be measured with the University of Pennsylvania Smell Identification Test (UPSIT) |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis |
|---|---|
| Official Title | Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis |
| Brief Summary | That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Primary Purpose: Treatment |
| Condition |
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| Intervention | Drug: pulmicort applied to nasal packing after surgery Other Names:
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| Study Arm (s) | Other: all subjects each subject serves as their own control |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | Not Provided |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | Not Provided |
| 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 f/u appt's |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Garrett R Griffin, MD 703-628-6424 gargriff@med.umich.edu |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01197612 |
|---|---|
| Other Study ID Numbers | HUM00029273 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | University of Michigan |
| Study Sponsor | University of Michigan |
| Collaborators | American Rhinologic Society |
| Investigators | Principal Investigator: Garrett R Griffin, MD University of Michigan |
| Verification Date | August 2010 |
Locations[ + expand ][ + ]
| University of Michigan | Ann Arbor, Michigan, United States, 48103 Contact: University of Michigan | 734-936-4000Sub-Investigator: Melissa Pynnonen, MD Recruiting |
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