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

NCT ID: NCT01197612

Last Updated: 2018-05-29

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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Conditions

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Chronic Sinusitis Polyposis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Single Arm; nostrils as experimental and comparator

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

Group Type OTHER

pulmicort

Intervention Type DRUG

applied to nasal packing after surgery

Interventions

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pulmicort

applied to nasal packing after surgery

Intervention Type DRUG

Other Intervention Names

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budesonide

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Rhinologic Society

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Garrett Griffin

Resident/Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Garrett R Griffin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00029273

Identifier Type: -

Identifier Source: org_study_id

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