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

Primary Purpose

Chronic Rhinosinusitis

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Mucosal Atomization Device (MAD)
Budesonide via Nasal Syringe
Sponsored by
St. Paul's Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • ENT Clinic, St. Paul's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Budesonide via MAD

Budesonide via Sinus Rinse Bottle

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

SNOT-22 questionnaire to measure subjective perspective.

Full Information

First Posted
July 26, 2011
Last Updated
March 7, 2014
Sponsor
St. Paul's Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01405339
Brief Title
Budesonide Application Via Mucosal Atomization Device as a Treatment for Chronic Rhinosinusitis When Utilized as a Topical Nasal Steroid Spray
Official Title
The Effect of Budesonide Spray Via Mucosal Atomization Device on the Hypothalamic-Pituitary Axis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Paul's Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Budesonide via MAD
Arm Type
Experimental
Arm Description
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.
Arm Title
Budesonide via Sinus Rinse Bottle
Arm Type
Active Comparator
Arm Description
Budesonide via Sinus Rinse Bottle is the most commonly used delivery method.
Intervention Type
Device
Intervention Name(s)
Mucosal Atomization Device (MAD)
Intervention Description
The use of pulmicort via MAD once a day for a total of 30 days.
Intervention Type
Device
Intervention Name(s)
Budesonide via Nasal Syringe
Intervention Description
The use of budesonide via Sinus Irrigation Bottle will be once a day for 30 days.
Primary Outcome Measure Information:
Title
Cosyntropin testing and blood work for quantification of plasma budesonide and plasma cortisol.
Time Frame
Participants will be followed for 30 days.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amin R Javer, MD, FRCSC, FARS
Organizational Affiliation
St. Paul's Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
ENT Clinic, St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15224630
Citation
Lund VJ, Black JH, Szabo LZ, Schrewelius C, Akerlund A. Efficacy and tolerability of budesonide aqueous nasal spray in chronic rhinosinusitis patients. Rhinology. 2004 Jun;42(2):57-62.
Results Reference
background
PubMed Identifier
19289711
Citation
Sachanandani NS, Piccirillo JF, Kramper MA, Thawley SE, Vlahiotis A. The effect of nasally administered budesonide respules on adrenal cortex function in patients with chronic rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):303-7. doi: 10.1001/archoto.2008.555.
Results Reference
background
PubMed Identifier
10518847
Citation
Scott MB, Skoner DP. Short-term and long-term safety of budesonide inhalation suspension in infants and young children with persistent asthma. J Allergy Clin Immunol. 1999 Oct;104(4 Pt 2):200-9. doi: 10.1016/s0091-6749(99)70062-x.
Results Reference
background
PubMed Identifier
19128710
Citation
Bhalla RK, Payton K, Wright ED. Safety of budesonide in saline sinonasal irrigations in the management of chronic rhinosinusitis with polyposis: lack of significant adrenal suppression. J Otolaryngol Head Neck Surg. 2008 Dec;37(6):821-5.
Results Reference
background
PubMed Identifier
18585575
Citation
Kanowitz SJ, Batra PS, Citardi MJ. Topical budesonide via mucosal atomization device in refractory postoperative chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2008 Jul;139(1):131-6. doi: 10.1016/j.otohns.2008.03.009.
Results Reference
background
PubMed Identifier
24449682
Citation
Thamboo A, Manji J, Szeitz A, Santos RD, Hathorn I, Gan EC, Alsaleh S, Javer AR. The safety and efficacy of short-term budesonide delivered via mucosal atomization device for chronic rhinosinusitis without nasal polyposis. Int Forum Allergy Rhinol. 2014 May;4(5):397-402. doi: 10.1002/alr.21280. Epub 2014 Jan 21.
Results Reference
derived

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

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