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

March 7, 2014 updated by: Amin Javer, St. Paul's Hospital, Canada

The Effect of Budesonide Spray Via Mucosal Atomization Device on the Hypothalamic-Pituitary Axis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • ENT Clinic, St. Paul's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 19 years of age or older
  • Diagnosed with CRS with or without polyps
  • Awaiting for Functional Endoscopic Sinus Surgery
  • Give consent on their own

Exclusion Criteria:

Concurrent or recent use (within the past 30 days) of systemic corticosteroids

  • History of pituitary disease
  • Morbid obesity (body mass index [calculated as weight in kilograms divided by height in meters squared]

  • Concurrent or recent use of medications that accelerate the clearance of cortisol:

    o Such as dilantin, rifampin, amphetamines, or lithium carbonate

  • Concurrent use of medications that interfere with the production of cortisol:

    o Such as ketoconazole, amphotericin B, bupropion, Echinacea, fluoroquinolones, itraconazole, licorice

  • Use of oral contraception
  • Use of female or male hormone therapy
  • Known hypersensitivity to cortisol, corticotropin, or cosyntropin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Budesonide via MAD
The current standard of care at St. Paul's Sinus Centre is to administer budesonide via the Mucosal Atomization Device (MAD). Its believed that MAD is a better device than the standard nasal lavage (Budesonide diluted in saline and delivered via Nasal Irrigation Bottle)because its fine mist and higher concentration enhances absorption and improves bioavailability.
Device: Mucosal Atomization Device (MAD)
The use of pulmicort via MAD once a day for a total of 30 days.
Active Comparator: Budesonide via Sinus Rinse Bottle
Budesonide via Sinus Rinse Bottle is the most commonly used delivery method.
Device: Budesonide via Nasal Syringe
The use of budesonide via Sinus Irrigation Bottle will be once a day for 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cosyntropin testing and blood work for quantification of plasma budesonide and plasma cortisol.
Time Frame: Participants will be followed for 30 days.
Participants will be followed for 30 days.

Secondary Outcome Measures

Outcome Measure
Time Frame
SNOT-22 questionnaire to measure subjective perspective.
Time Frame: Participants will be followed for the duration of post op standard of care, an expected average of 6 months.
Participants will be followed for the duration of post op standard of care, an expected average of 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Paul's Hospital, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 26, 2011

First Submitted That Met QC Criteria

July 28, 2011

First Posted (Estimate)

July 29, 2011

Study Record Updates

Last Update Posted (Estimate)

March 10, 2014

Last Update Submitted That Met QC Criteria

March 7, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSMAD2011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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