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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01405339

Enrollment

Registered

2011-07-29

Start date

2011-08-31

Completion date

2014-01-31

Last updated

2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis

Brief 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.

Interventions

DEVICEMucosal Atomization Device (MAD)

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

DEVICEBudesonide via Nasal Syringe

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026