Effect of budesonide nasal irrigation on Hypothalamus-Pituitary-Adrenal Axis in patients with chronic rhinosinusitis post endoscopic sinus surgery
Phase 4
Completed
- Conditions
- To evaluate safety of long-term budesonide nasal irrigation in the patients with chronic rhinosinusitis after post-endoscopic sinus surgery by serum morning cortisol level
- Registration Number
- TCTR20191016001
- Lead Sponsor
- ENT department, Chulalongkorn hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
1. Patients with chronic rhinosinusitis with/without nasal polyp who had planned to receive endoscopic sinus surgery with post-operative budesonide nasal irrigation 0.5mg/day or more.
2. Age 18-70 years old
Exclusion Criteria
1. Patients with pituitary disease, adrenal gland disease, or morbid obesity
2. Patients who received systemic glucocorticoids (intravenous, intramuscular, and oral form) during experiment except for the treatment of chronic rhinosinusitis
3. Patients who had pregnancy.
4. Patients who had medications that effect cortisol.
5. Patients who underwent estrogen therapy or received estrogen oral contraceptive pill.
6. Patients who had abnormal serum morning cortisol before nasal irrigation.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum morning cortisol level 0,3,6 months Blood test
- Secondary Outcome Measures
Name Time Method /A N/A N/A