NCT03584178

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

September 5, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

2.3 years

First QC Date

June 18, 2018

Last Update Submit

September 18, 2019

Conditions

Sinusitis

Keywords

ACTH-axisBudesonideMADINSIIntraocular pressureBone density

Outcome Measures

Primary Outcomes (1)

  • 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).

    1 year

Study Arms (2)

Mucosal Atomization Device

EXPERIMENTAL

Budesonide via MAD Device

Device: Budesonide via MAD device

Intranasals Saline Irrigation

EXPERIMENTAL

Budesonide via Intranasals Saline Irrigation

Device: Budesonide via intranasals Saline Irrigation

Interventions

Budesonide via MAD deviceDEVICE

Delivery through Mucosal Atomization Device

Also known as: Budesonide via Mucosal Atomization Device
Mucosal Atomization Device
Budesonide via intranasals Saline IrrigationDEVICE

delivery via nasal irrigation bottle

Also known as: Intranasals Saline Irrigation
Intranasals Saline Irrigation

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Paul Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Amin Javer, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amin Javer, MD

CONTACT

6048069926sinusdoc@me.com

Sara Derikvand, PhD

CONTACT

6048069926stpaulsinusresearch@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, St. Paul's Sinus Centre

Study Record Dates

First Submitted

June 18, 2018

First Posted

July 12, 2018

Study Start

September 5, 2018

Primary Completion

December 25, 2020

Study Completion

December 25, 2021

Last Updated

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)