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

University of Michigan

Status and phase: Completed; Phase 3

Conditions: Chronic Sinusitis; Polyposis

Treatments: Drug: pulmicort

Study type: Interventional

Funder types: Other

Identifiers

NCT01197612

HUM00029273

Details and patient eligibility

About

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

Enrollment: 23 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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23 participants in 1 patient group

Single Arm; nostrils as experimental and comparator

Other group

Description:

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

Treatment:

Drug: pulmicort