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Trial of Directed High-dose Nasal Steroids on Residual Smell Loss in Sinus Patients After Sinus Surgery

NCT01814618 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-04-06

No results posted yet for this study

Summary

The purpose of this study is to determine if a trial of directed high-dose nasal steroids improves residual smell loss in patients with chronic rhinosinusitis following sinus surgery. Other outcomes of this study include: identifying the differences in sinus airflow between patients who improve following nasal steroid treatment and those who do not, and to see if, in patients who improve following surgery, the improvement remains throughout follow-up.

Conditions

  • Olfaction Disorders
  • Sinusitis
  • Paranasal Sinus Diseases

Interventions

DRUG

Budesonide Respules

Subjects irrigate their noses with budesonide respules. They will use one respule per nostril twice daily for three months.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Adam M Zanation, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-11-30
Completion
2013-11-30

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 NCT01814618 on ClinicalTrials.gov