Treatment of Early Nasal Polyposis With Topical Triamcinolone

June 27, 2018 updated by: Peter Catalano, Steward St. Elizabeth's Medical Center of Boston, Inc.
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • St. Elizabeth's Medical Center, 736 Cambridge St

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Triamcinolone
Triamcinolone soaked nasopore dressing
Drug: Triamcinolone
Triamcinolone soaked nasopore dressing
Other Names:
  • Kenalog (40)
Placebo Comparator: Control Group
Saline soaked sponge
Drug: Saline soaked sponge
saline soaked sponge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal Endoscopic Exam Findings .
Time Frame: 2 weeks, 6 weeks, 12 weeks were not collected from any participant.
nasal endoscopic exam findings at 2 weeks, 6 weeks and 12 weeks were not collected from any participant.
2 weeks, 6 weeks, 12 weeks were not collected from any participant.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steward St. Elizabeth's Medical Center of Boston, Inc.

Investigators

  • Study Director: Peter Catalano, MD, Steward St. Elizabeth's Medical Center of Boston, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

October 15, 2010

First Posted (Estimate)

October 18, 2010

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00540

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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