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Budesonide Application Via Mucosal Atomization Device as a Treatment for Chronic Rhinosinusitis When Utilized as a Topical Nasal Steroid Spray

NCT01405339 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-03-10

No results posted yet for this study

Summary

Budesonide, a steroid subtype, has been used as an adjunctive treatment for chronic rhinosinusitis as a topical nasal steroid spray. The current standard of care at St. Paul's Sinus Centre is to administer budesonide via the Mucosal Atomization Device (MAD). It is believed that the MAD is a better device than the standard nasal lavage because its fine mist enhances absorption and improves bioavailability. No studies have been done to determine if enhanced absorption and improved bioavailability of budesonide via MAD could potentially affect the hypothalamic-pituitary-adrenal (HPA) axis, resulting in the suppression of our own body's production of natural steroids.

Conditions

  • Chronic Rhinosinusitis

Interventions

DEVICE

Mucosal Atomization Device (MAD)

The use of pulmicort via MAD once a day for a total of 30 days.

DEVICE

Budesonide via Nasal Syringe

The use of budesonide via Sinus Irrigation Bottle will be once a day for 30 days.

Sponsors & Collaborators

  • St. Paul's Hospital, Canada

    lead OTHER

Principal Investigators

  • Amin R Javer, MD, FRCSC, FARS · St. Paul's Hospital, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-05-31
Completion
2014-01-31

Countries

  • Canada

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 NCT01405339 on ClinicalTrials.gov