Back to resultsTreatment of Early Nasal Polyposis With Topical Triamcinolone
Primary Purpose
Nasal Polyps
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Triamcinolone
Saline soaked sponge
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Polyps focused on measuring Treatment
Eligibility Criteria
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
Sites / Locations
- St. Elizabeth's Medical Center, 736 Cambridge St
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Triamcinolone
Control Group
Arm Description
Triamcinolone soaked nasopore dressing
Saline soaked sponge
Outcomes
Primary Outcome Measures
Nasal Endoscopic Exam Findings .
nasal endoscopic exam findings at 2 weeks, 6 weeks and 12 weeks were not collected from any participant.
Secondary Outcome Measures
Full Information
NCT ID
NCT01222871
First Posted
October 14, 2010
Last Updated
June 27, 2018
Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01222871
Brief Title
Treatment of Early Nasal Polyposis With Topical Triamcinolone
Official Title
Treatment of Early Nasal Polyposis With Topical Triamcinolone
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
not enough particpants
Study Start Date
July 2010 (Actual)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Steward St. Elizabeth's Medical Center of Boston, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Polyps
Keywords
Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients will be randomized into 2 study groups, experimental and control.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triamcinolone
Arm Type
Experimental
Arm Description
Triamcinolone soaked nasopore dressing
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Saline soaked sponge
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Other Intervention Name(s)
Kenalog (40)
Intervention Description
Triamcinolone soaked nasopore dressing
Intervention Type
Drug
Intervention Name(s)
Saline soaked sponge
Intervention Description
saline soaked sponge
Primary Outcome Measure Information:
Title
Nasal Endoscopic Exam Findings .
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Catalano, MD
Organizational Affiliation
Steward St. Elizabeth's Medical Center of Boston, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
St. Elizabeth's Medical Center, 736 Cambridge St
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Treatment of Early Nasal Polyposis With Topical Triamcinolone
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