Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-26 @ 10:33 AM
NCT ID:
NCT01373528
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01373528
Study Brief:
Protocol Section:
NCT01373528