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Treatment of Early Nasal Polyposis With Topical Triamcinolone

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ClinicalTrials.gov Identifier: NCT01222871
Recruitment Status : Terminated (not enough particpants)
First Posted : October 18, 2010
Results First Posted : June 28, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Catalano, Steward St. Elizabeth's Medical Center of Boston, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nasal Polyps Drug: Triamcinolone Drug: Saline soaked sponge Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Patients will be randomized into 2 study groups, experimental and control.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Early Nasal Polyposis With Topical Triamcinolone
Actual Study Start Date : July 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Triamcinolone
Triamcinolone soaked nasopore dressing
 Drug: Triamcinolone
Triamcinolone soaked nasopore dressing
Other Name: Kenalog (40)
Placebo Comparator: Control Group
Saline soaked sponge
 Drug: Saline soaked sponge
saline soaked sponge


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01222871


Locations
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United States, Massachusetts
St. Elizabeth's Medical Center, 736 Cambridge St
Brighton, Massachusetts, United States, 02135
Sponsors and Collaborators
Steward St. Elizabeth's Medical Center of Boston, Inc.
Investigators
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Study Director: Peter Catalano, MD Steward St. Elizabeth's Medical Center of Boston, Inc.
More Information
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Responsible Party: Peter Catalano, Chief of Otolaryngology, Steward St. Elizabeth's Medical Center of Boston, Inc.
ClinicalTrials.gov Identifier: NCT01222871    
Other Study ID Numbers: 00540
First Posted: October 18, 2010    Key Record Dates
Results First Posted: June 28, 2018
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Peter Catalano, Steward St. Elizabeth's Medical Center of Boston, Inc.:
Treatment
Additional relevant MeSH terms:
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Nasal Polyps
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
 Triamcinolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs