Impact of Topical Sinonasal Budesonide Irrigation on Hypothalamic-Pituitary-Adrenal Axis Function

NCT01373528 | Terminated DMC

• 1 other identifier: 2010249-01H
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic rhinosinusitis (CRS) is a complex inflammatory disease that is treated primarily with sinus surgery and the long-term use of topical steroid therapy. Budesonide irrigation is a common method of topical steroid treatment for these patients. However, the effects of budesonide irrigation on the hypothalamic-pituitary-adrenal (HPA) axis in patients with CRS following sinus surgery, is as of yet not defined. The objective of this study is to determine if topical sinonasal budesonide steroid irrigation leads to acute recoverable and/or long-term suppression of the HPA axis. Participants in this prospective cohort study will have CRS and have recently undergone endoscopic sinus surgery. They will also have had planned use of budesonide irrigations as their postoperative medical treatment. The acute effects of this treatment on the HPA axis will be evaluated using serial serum cortisol measurements both the day before and the day of the first budesonide irrigation. The long-term effect of sinonasal budesonide irrigation will be evaluated using both a pre- and post-treatment adrenocorticotropic hormone (ACTH) stimulation test as well as repeated urine free cortisol levels over the length of the study. The results will determine the need for additional steroids when patients stop treatment or with a physiologic stressful event.

Conditions

Chronic Rhinosinusitis

Keywords

Sinonasal Budesonide; Endoscopic sinus surgery; Hypothalamic-Pituitary-Adrenal Axis Function

Outcome Measures

Primary Outcomes (3)

• Serum cortisol levels before and after treatment

  12 months

• ACTH stimulation test cortisol level

  12 months

• Urinary Free Cortisol Levels

  Every 3 months

Study Arms (1)

Budesonide

EXPERIMENTAL

Drug: Budesonide irrigation

Interventions

Budesonide irrigation DRUG

A budesonide (1 mg) in saline (240 mL) irrigation solution is applied to the sinonasal cavities twice daily. 120 mL of the solution is applied via irrigation in the AM, and 120 mL again in the PM.

Budesonide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting adult patients (age ≥18) who are diagnosed with CRS
• Patient already determined to need surgical treatment having failed medical management
• Patients planned to be treated with budesonide irrigations as postoperative maintenance therapy

You may not qualify if:

• Patients with pre-operative symptoms and signs of HPA dysfunction
• Patients with signs and symptoms of untreated endocrine disorders such as hypothyroidism, hypopituitarism, hypogonadism. Screening for thyroid disease will be done with a TSH, T3 and free T4 for each participant.
• Patients with known history of liver disease or abnormal AST/ALT lab tests
• Any history of oral glucocorticoid use in the past 4 months
• Patients with a known history of glaucoma
• Patients with known tuberculosis (TB)- active or latent
• Patients taking drugs that affect cortisol synthesis (mifepristomine, itraconazole, ketoconazole, erythromycin, clarithromycin, cimetidine) or protein binding drugs (estrogens and androgens)
• A known sensitivity to topical budesonide
• Pregnant and/or breast feeding woman
• Presence of multiple co-morbidities such as poorly controlled diabetes, chronic renal failure, hepatic failure
• Inability to provide informed consent

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Riverside Campus

Ottawa, Ontario, K1H 4E9, Canada

Location

Study Officials

• Kilty Shaun, MD

  OHRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2011
• First Posted: June 15, 2011
• Study Start: December 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 18, 2012

Record last verified: 2012-05

Locations

CA (1)