Recruiting

Budesonide

Sponsor:

St. Paul's Hospital, Canada

Code:

NCT03584178

Conditions

Sinusitis

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Budesonide via MAD device

Budesonide via intranasals Saline Irrigation

Study Details

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.

Conditions

Sinusitis

Study ID

NCT03584178

Start date

Sep 5, 2018

Status verified date

Sep, 2019

Completion date

Dec 25, 2021

Anticipated

Primary completion date

Dec 25, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Mucosal Atomization Device

Budesonide via MAD Device

experimental: Intranasals Saline Irrigation

Budesonide via Intranasals Saline Irrigation

Interventions

Budesonide via MAD device

Delivery through Mucosal Atomization Device

Budesonide via intranasals Saline Irrigation

delivery via nasal irrigation bottle

Primary outcome measure

  • Sinonasal-Outcomes Test-22 (SNOT-22) Questionnaire [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Amin Javer, MD

6048069926sinusdoc@me.com

Sara Derikvand, PhD

6048069926stpaulsinusresearch@gmail.com

Locations

St Paul Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Sara Derikvand, PhD

6048069926stpaulsinusresearch@gmail.com

Amin Javer, MD

6048069926sinusdoc@me.com

Principal Investigator:

Amin R Javer, MD

More Information

Sponsor

St. Paul's Hospital, Canada

Last update posted

Sep 20, 2019

Last verified

Sep, 2019

Keywords

  • ACTH-axis
  • Budesonide
  • MAD
  • INSI
  • Intraocular pressure
  • Bone density

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Paul's Hospital, Canada on 2019-09-20.