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Comparison of Nasal Steroids After FESS in CRSwNP

NCT02194062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-02-08

Study results available
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Summary

The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal saline rinses in both the upright and head forward positions in patients who have had functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis with nasal polyposis (CRSwNP) and measure differences in Sinonasal Outcome Test-22 (SNOT-22) scores and Lund- Kennedy scores on rigid nasal endoscopy at time points 1 week, 3 weeks, 6 weeks, 2 months, 4 months, and 6 months post-op.

Conditions

  • Sinusitis
  • Nasal Polyps

Interventions

DRUG

fluticasone nasal spray

use 2-50 mcg sprays to each nostril two times per day

DRUG

Budesonide head upright

(0.5 mg/2mL) to instill into each nostril in the upright position two times per day

DRUG

Budesonide head forward

(0.5 mg/2mL) to instill into each nostril in the head forward position two times per day

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • R. Peter Manes, MD · Yale University School of Medicine, Asst Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-07-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02194062 on ClinicalTrials.gov