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

NCT ID: NCT03584178

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-05
• Study Completion Date: 2021-12-25

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.

Conditions

Sinusitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mucosal Atomization Device

Budesonide via MAD Device

Group Type: EXPERIMENTAL

Budesonide via MAD device

Intervention Type: DEVICE

Delivery through Mucosal Atomization Device

Intranasals Saline Irrigation

Budesonide via Intranasals Saline Irrigation

Group Type: EXPERIMENTAL

Budesonide via intranasals Saline Irrigation

Intervention Type: DEVICE

delivery via nasal irrigation bottle

Interventions

Budesonide via MAD device

Delivery through Mucosal Atomization Device

Intervention Type: DEVICE

Budesonide via intranasals Saline Irrigation

delivery via nasal irrigation bottle

Intervention Type: DEVICE

Other Intervention Names

Budesonide via Mucosal Atomization Device; Intranasals Saline Irrigation

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Paul's Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Amin Javer

Director, St. Paul's Sinus Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amin Javer, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

St Paul Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Amin Javer, MD

Role: CONTACT

sinusdoc@me.com

6048069926

Sara Derikvand, PhD

Role: CONTACT

stpaulsinusresearch@gmail.com

6048069926

Facility Contacts

Sara Derikvand, PhD

Role: primary

stpaulsinusresearch@gmail.com

6048069926

Amin Javer, MD

Role: backup

sinusdoc@me.com

6048069926

Other Identifiers

H18-00458

Identifier Type: -

Identifier Source: org_study_id