Trial record 7 of 66 for: Open Studies | "Sinusitis"

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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2010 by University of Michigan.
Recruitment status was Recruiting

Sponsor:

Collaborator:

American Rhinologic Society

Information provided by:

University of Michigan

ClinicalTrials.gov Identifier:

NCT01197612

First received: August 30, 2010

Last updated: September 8, 2010

Last verified: August 2010

History of Changes

Purpose

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

Condition	Intervention	Phase
Chronic Sinusitis Polyposis	Drug: pulmicort	Phase 3

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:

olfaction [ Time Frame: 3 weeks post-op ] [ Designated as safety issue: No ]
will be measured with the University of Pennsylvania Smell Identification Test (UPSIT)

Secondary Outcome Measures:

Sinonasal health [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
will be assessed with the Perioperative Sinus Endoscopy score (POSE)
Olfaction [ Time Frame: 24 weeks post-op ] [ Designated as safety issue: No ]
Scored with the University of Pennsylvania Smell Identification Test
Sinonasal health [ Time Frame: 24 weeks post-op ] [ Designated as safety issue: No ]
Assessed with Perioperative Sinus Endoscopy (POSE) score

Study Start Date:

September 2010

Arms	Assigned Interventions
all subjects each subject serves as their own control	Drug: pulmicort applied to nasal packing after surgery Other Names: pulmicort budesonide

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 f/u appt's

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197612

Contacts

Contact: Garrett R Griffin, MD

703-628-6424

gargriff@med.umich.edu

Locations

United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48103
Contact: University of Michigan 734-936-4000
Sub-Investigator: Melissa Pynnonen, MD
Sub-Investigator: Jeff Terrell, MD

Sponsors and Collaborators

University of Michigan

American Rhinologic Society

Investigators

Principal Investigator:

Garrett R Griffin, MD

University of Michigan

More Information

No publications provided

Responsible Party:	Garrett Griffin, University of Michigan Department of Otolaryngology
ClinicalTrials.gov Identifier:	NCT01197612 History of Changes
Other Study ID Numbers:	HUM00029273
Study First Received:	August 30, 2010
Last Updated:	September 8, 2010
Health Authority:	United States: Institutional Review Board United States: American Rhinologic Society

Additional relevant MeSH terms:

Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013

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