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

Phase 3CompletedNCT01197612

University of Michigan23 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Sinusitis Polyposis

Interventions

pulmicortDRUG

applied to nasal packing after surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Olfaction

will be measured with the University of Pennsylvania Smell Identification Test (UPSIT), whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification

Time frame: 3 weeks post-operation

Secondary Outcomes

Sinonasal Health

will be assessed with the Perioperative Sinus Endoscopy score (POSE), a 20 point scale where 0 is no sinus challenges and 20 represents the greatest blockage.

Time frame: 3 weeks post operation

Olfaction

Scored with the University of Pennsylvania Smell Identification Test, whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification

Time frame: 24 weeks post operation

Sinonasal Health

Assessed with Perioperative Sinus Endoscopy (POSE) score

Time frame: 24 weeks post operation

Data from ClinicalTrials.gov

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