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Completed

NCT Number: NCT01405339

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

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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Key information

Conditions

Chronic Rhinosinusitis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

ENT Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mucosal Atomization Device (MAD)

Device

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

Budesonide via Nasal Syringe

Device

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

Primary outcomes

  1. Cosyntropin testing and blood work for quantification of plasma budesonide and plasma cortisol.

    Time frame: Participants will be followed for 30 days.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

St. Paul's Hospital, Canada

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jul 29, 2011
Registry last updated
Mar 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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