Treatment of Early Nasal Polyposis With Topical Triamcinolone

NCT ID: NCT01222871

Last Updated: 2018-06-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Nasal Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Patients will be randomized into 2 study groups, experimental and control.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Triamcinolone

Triamcinolone soaked nasopore dressing

Group Type EXPERIMENTAL

Triamcinolone

Intervention Type DRUG

Triamcinolone soaked nasopore dressing

Control Group

Saline soaked sponge

Group Type PLACEBO_COMPARATOR

Saline soaked sponge

Intervention Type DRUG

saline soaked sponge

Interventions

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Triamcinolone

Triamcinolone soaked nasopore dressing

Intervention Type DRUG

Saline soaked sponge

saline soaked sponge

Intervention Type DRUG

Other Intervention Names

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Kenalog (40)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Peter Catalano

Chief of Otolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Catalano, MD

Role: STUDY_DIRECTOR

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

Locations

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St. Elizabeth's Medical Center, 736 Cambridge St

Brighton, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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00540

Identifier Type: -

Identifier Source: org_study_id

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