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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Rhinosinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mucosal Atomization Device (MAD)

Intervention Type DEVICE

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

Budesonide via Sinus Rinse Bottle

Budesonide via Sinus Rinse Bottle is the most commonly used delivery method.

Group Type ACTIVE_COMPARATOR

Budesonide via Nasal Syringe

Intervention Type DEVICE

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

Interventions

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Mucosal Atomization Device (MAD)

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

Intervention Type DEVICE

Budesonide via Nasal Syringe

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No