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

Chronic Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197612
• Other study ID #: HUM00029273
• Status: Completed
• Phase: Phase 3
• Start date: September 2010
• Est. completion date: June 2012

Study information

• Verified date: April 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Colorectal Neoplasms
• Nasopharyngeal Neoplasms
• Polyposis
• Sinusitis

Intervention

Drug:
• pulmicort
applied to nasal packing after surgery

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	American Rhinologic Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 weeks post-operation
Secondary	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.	3 weeks post operation
Secondary	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	24 weeks post operation
Secondary	Sinonasal Health	Assessed with Perioperative Sinus Endoscopy (POSE) score	24 weeks post operation