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

Tracking Information

First Received Date ^ICMJE

August 30, 2010

Last Updated Date

September 8, 2010

Start Date ^ICMJE

September 2010

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

olfaction [ Time Frame: 3 weeks post-op ] [ Designated as safety issue: No ]

will be measured with the University of Pennsylvania Smell Identification Test (UPSIT)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01197612 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Chronic
Sinusitis
Polyposis

Intervention ^ICMJE

Drug: pulmicort

applied to nasal packing after surgery

Other Names:

pulmicort
budesonide

Study Arm (s)

all subjects

each subject serves as their own control

Intervention: Drug: pulmicort

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Garrett R Griffin, MD

703-628-6424

gargriff@med.umich.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01197612

Other Study ID Numbers ^ICMJE

HUM00029273

Has Data Monitoring Committee

Yes

Responsible Party

Garrett Griffin, University of Michigan Department of Otolaryngology

Study Sponsor ^ICMJE

University of Michigan

Collaborators ^ICMJE

American Rhinologic Society

Investigators ^ICMJE

Principal Investigator:

Garrett R Griffin, MD

University of Michigan

Information Provided By

University of Michigan

Verification Date

August 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top