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Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis

Primary Purpose

Chronic Sinusitis, Polyposis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
pulmicort
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm; nostrils as experimental and comparator

Arm Description

each subject serves as their own control with one nostril being treated with pulmicort and one not

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
Sinonasal Health
Assessed with Perioperative Sinus Endoscopy (POSE) score

Full Information

First Posted
August 30, 2010
Last Updated
April 24, 2018
Sponsor
University of Michigan
Collaborators
American Rhinologic Society
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1. Study Identification

Unique Protocol Identification Number
NCT01197612
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (Actual)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
American Rhinologic Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis, Polyposis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm; nostrils as experimental and comparator
Arm Type
Other
Arm Description
each subject serves as their own control with one nostril being treated with pulmicort and one not
Intervention Type
Drug
Intervention Name(s)
pulmicort
Other Intervention Name(s)
budesonide
Intervention Description
applied to nasal packing after surgery
Primary Outcome Measure Information:
Title
Olfaction
Description
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
Time Frame
3 weeks post-operation
Secondary Outcome Measure Information:
Title
Sinonasal Health
Description
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.
Time Frame
3 weeks post operation
Title
Olfaction
Description
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
Time Frame
24 weeks post operation
Title
Sinonasal Health
Description
Assessed with Perioperative Sinus Endoscopy (POSE) score
Time Frame
24 weeks post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garrett R Griffin, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States

12. IPD Sharing Statement

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Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis

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