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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amin Javer, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01405339
First received: July 26, 2011
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Chronic Rhinosinusitis
Device: Mucosal Atomization Device (MAD)
Device: Budesonide via Nasal Syringe
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Budesonide Spray Via Mucosal Atomization Device on the Hypothalamic-Pituitary Axis

Resource links provided by NLM:


Further study details as provided by St. Paul's Hospital, Canada:

Primary Outcome Measures:
  • Cosyntropin testing and blood work for quantification of plasma budesonide and plasma cortisol. [ Time Frame: Participants will be followed for 30 days. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2011
Study Completion Date: January 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405339

Locations
Canada, British Columbia
ENT Clinic, St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Sponsors and Collaborators
St. Paul's Hospital, Canada
Investigators
Principal Investigator: Amin R Javer, MD, FRCSC, FARS St. Paul's Hospital, Canada
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amin Javer, MD FRCSC FARS, Principal Investigator, Director of St Paul's Sinus Centre, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT01405339     History of Changes
Other Study ID Numbers: PSMAD2011
Study First Received: July 26, 2011
Last Updated: March 7, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Budesonide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014