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The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis

Primary Purpose

Sinusitis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Budesonide via MAD device
Budesonide via intranasals Saline Irrigation
Sponsored by
St. Paul's Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sinusitis focused on measuring ACTH-axis, Budesonide, MAD, INSI, Intraocular pressure, Bone density

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients aged between 19 years and above
  2. Patients with chronic or recurrent sinusitis (as defined by the American Academy of Otolaryngology) with nasal polyposis
  3. Patients with an upcoming Functional Endoscopic Sinus Surgery (FESS) procedure
  4. Patients being prescribed INCS for the first time following FESS

Exclusion Criteria:

  1. Individuals unable to understand the purpose, methods and conduct of this study
  2. Patients unwilling to provide informed consent
  3. Patients with significant comorbidities (such as tumour, CF, wegeners granulomatosis, immunocompromised)
  4. Patients with a history of pituitary disease
  5. Patients with a known hypersensitivity to cortisol, corticotropin, or cosyntropin
  6. Patients with history of glaucoma or cataracts
  7. Recent use of systemic corticosteroids such as prednisone (within last 3 months)
  8. Patients that are not adherent to budesonide via MAD/INSI treatment

Sites / Locations

  • St Paul HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mucosal Atomization Device

Intranasals Saline Irrigation

Arm Description

Budesonide via MAD Device

Budesonide via Intranasals Saline Irrigation

Outcomes

Primary Outcome Measures

Sinonasal-Outcomes Test-22 (SNOT-22) Questionnaire
This sinus-specific questionnaire is divided into three parts consisting of 22 questions that are related to sinus health and health-related quality of life. This questionnaire was developed to assess symptoms and quality of life in patients suffering from CRS with or without nasal polyposis. Each question is scored on an ordinal, categorical scale ranging from 0 to 5. Patients are instructed to indicate if symptoms are "absent (0)", "very mild (1)", "mild (2)", "moderate (3)", "severe (4)" or "as bad as it can be (5)". The highest score achievable on this questionnaire is 110 points. Higher scores indicate greater symptom severity and burden on daily life. In a validation survey of 2803 subjects, the SNOT-22 showed high internal consistency, test-retest reliability and validity. The SNOT-22 was found to sufficiently distinguish between patients with CRS and healthy controls (P<0.0001, t=85.3).

Secondary Outcome Measures

Full Information

First Posted
June 18, 2018
Last Updated
September 18, 2019
Sponsor
St. Paul's Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03584178
Brief Title
The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis
Official Title
The Long-Term Safety of Budesonide Via Mucosal Atomization Device and Impregnated Nasal Saline Irrigations for Patients With Chronic Rhinosinusitis - A Prospective Double Cohort Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
December 25, 2020 (Anticipated)
Study Completion Date
December 25, 2021 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic Rhinosinusitis (CRS) is a common disorder of the nose. The current practice at St Paul's Sinus Centre is to prescribe budesonide via the mucosal atomization device or impregnated saline irrigation. Both have shown to be a safe method of administration. A previous study demonstrated a 6% elevation in intraocular pressure and 3% prevalence of asymptomatic AdrenoCorticoTropic Hormone-Axis (ACTH) suppression. However, a baseline measurement was not conducted to ascertain the correlation of these findings with the medication. Therefore, the investigators aim to conduct baseline measurements of IntraOcular Pressure (IOP), ACTH-axis function, and Dual Energy X-ray Absorptiometry (DEXA) scan and obtaining regular measurements of these variables within a 12-month period to further ascertain these previous findings.
Detailed Description
Purpose: The purpose of this study is to assess the long-term effects of budesonide via MAD (Mucosal Atomization Device) or INSI (Intranasal Saline Irrigation) on intraocular pressure, ACTH-axis function, and bone-density. Hypothesis: Budesonide delivered via MAD or INSI will be safe in the long-term (> 12 months) demonstrated objectively via IOP, ACTH stimulation test, and DEXA scan. Justification: The safety profile of both MAD and INSI has been widely studied in the literature. Although both modalities are generally considered safe, several studies have demonstrated asymptomatic hypothalamic-pituitary-adrenal axis (HPAA) suppression when used in the long-term. A cross-sectional study at St Paul's Sinus Centre, found 3% of study participants on long-term maintenance treatment via MAD to have asymptomatic HPAA suppression. However, the cross-sectional study design limited the ability to ascertain the timeline for this adverse event. Although the recent cross-sectional study at St Paul Sinus Centre was the first to study the long-term effects of budesonide via the MAD in CRS patients, it did not include baseline levels of HPAA function and IOP levels which served as a limitation to ascertaining the timeline of the aforementioned adverse events. Additionally, there is currently limited data on the effects of INCS on bone function in the setting of CRS treatment. Therefore, this study aims to prospectively assess the long-term effect of high-dose nasal corticosteroids (i.e. INSI and MAD) in CRS patients. The study design will obtain baseline measurements of ACTH function, IOP measurement, and a DEXA scan to identify and describe the timeline of adverse events should they develop during the 12-month study period. By determining the impact of nasal corticosteroids on these outcomes, potential improvements can be made in the safety monitoring practices of otolaryngologists. This may include more frequent monitoring of intraocular pressure, Bone Mineral Density (BMD), and HPAA-axis function in at-risk populations, development of budesonide tapering guidelines, and improved screening of patient-reported adverse events. Overall, the investigators hope the results from this study will be a step forward in the development of screening guidelines for monitoring patients on long-term IntraNasal CorticoSteroids (INCS) therapy. Primary Objective: To assess long-term safety (> 12 months) of budesonide delivered via MAD or INSI as measured objectively via IOP, ACTH stimulation test, and DEXA scan. Research Design: A Prospective Double-Cohort Study Statistical Analysis: Descriptive statistics will be used to analyze the baseline characteristic data and the data from the administered surveys and objective findings of ACTH stimulation test, IOP measurement, and DEXA scans. In addition, rigorous statistical analysis will be conducted on the Likert scale-based SinoNasal Outcome Test (SNOT-22) and EuroQuol health-related quality of life surveys (EQ-5D-5L). These analyses will include cross-tabulations (Pearson's chi square test) and confidence interval calculations. Due to the variations in baseline intraocular pressure measurements, the investigators will calculate an adjusted difference instead of absolute values.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
ACTH-axis, Budesonide, MAD, INSI, Intraocular pressure, Bone density

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mucosal Atomization Device
Arm Type
Experimental
Arm Description
Budesonide via MAD Device
Arm Title
Intranasals Saline Irrigation
Arm Type
Experimental
Arm Description
Budesonide via Intranasals Saline Irrigation
Intervention Type
Device
Intervention Name(s)
Budesonide via MAD device
Other Intervention Name(s)
Budesonide via Mucosal Atomization Device
Intervention Description
Delivery through Mucosal Atomization Device
Intervention Type
Device
Intervention Name(s)
Budesonide via intranasals Saline Irrigation
Other Intervention Name(s)
Intranasals Saline Irrigation
Intervention Description
delivery via nasal irrigation bottle
Primary Outcome Measure Information:
Title
Sinonasal-Outcomes Test-22 (SNOT-22) Questionnaire
Description
This sinus-specific questionnaire is divided into three parts consisting of 22 questions that are related to sinus health and health-related quality of life. This questionnaire was developed to assess symptoms and quality of life in patients suffering from CRS with or without nasal polyposis. Each question is scored on an ordinal, categorical scale ranging from 0 to 5. Patients are instructed to indicate if symptoms are "absent (0)", "very mild (1)", "mild (2)", "moderate (3)", "severe (4)" or "as bad as it can be (5)". The highest score achievable on this questionnaire is 110 points. Higher scores indicate greater symptom severity and burden on daily life. In a validation survey of 2803 subjects, the SNOT-22 showed high internal consistency, test-retest reliability and validity. The SNOT-22 was found to sufficiently distinguish between patients with CRS and healthy controls (P<0.0001, t=85.3).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged between 19 years and above Patients with chronic or recurrent sinusitis (as defined by the American Academy of Otolaryngology) with nasal polyposis Patients with an upcoming Functional Endoscopic Sinus Surgery (FESS) procedure Patients being prescribed INCS for the first time following FESS Exclusion Criteria: Individuals unable to understand the purpose, methods and conduct of this study Patients unwilling to provide informed consent Patients with significant comorbidities (such as tumour, CF, wegeners granulomatosis, immunocompromised) Patients with a history of pituitary disease Patients with a known hypersensitivity to cortisol, corticotropin, or cosyntropin Patients with history of glaucoma or cataracts Recent use of systemic corticosteroids such as prednisone (within last 3 months) Patients that are not adherent to budesonide via MAD/INSI treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amin Javer, MD
Phone
6048069926
Email
sinusdoc@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Derikvand, PhD
Phone
6048069926
Email
stpaulsinusresearch@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amin Javer, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Paul Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Derikvand, PhD
Phone
6048069926
Email
stpaulsinusresearch@gmail.com
First Name & Middle Initial & Last Name & Degree
Amin Javer, MD
Phone
6048069926
Email
sinusdoc@me.com
First Name & Middle Initial & Last Name & Degree
Amin R Javer, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis

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