Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
1 other identifier
interventional
23
1 country
1
Brief Summary
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedFirst Posted
Study publicly available on registry
September 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
May 29, 2018
CompletedMay 29, 2018
April 1, 2018
1.8 years
August 30, 2010
April 24, 2018
April 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Sinonasal Health
3 weeks post operation
Olfaction
24 weeks post operation
Sinonasal Health
24 weeks post operation
Study Arms (1)
Single Arm; nostrils as experimental and comparator
OTHEReach subject serves as their own control with one nostril being treated with pulmicort and one not
Interventions
applied to nasal packing after surgery
Eligibility Criteria
You may qualify if:
- hyposmia and nasal obstruction for \>12 weeks
- bilateral nasal polyposis
- candidate for surgery
You may not qualify if:
- immunocompromised
- non-English speaking
- prisoner
- pregnant/lactating
- will not attend follow up appointments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- American Rhinologic Societycollaborator
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48103, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Garrett Griffin, MD
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Garrett R Griffin, MD
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident/Research Fellow
Study Record Dates
First Submitted
August 30, 2010
First Posted
September 9, 2010
Study Start
September 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
May 29, 2018
Results First Posted
May 29, 2018
Record last verified: 2018-04