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:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT02696850
Eligibility Criteria:
Inclusion Criteria:
Twelve (12) weeks or longer of two or more of the following signs and symptom consistent with chronic rhinosinusitis (CRS)
• mucopurulent drainage (anterior, posterior, or both), nasal obstruction (congestion),facial pain-pressure-fullness, and decreased sense of smell
AND inflammation documented by one or more of the following findings:
* purulent (not clear) mucus or edema in the middle meatus or ethmoid region,
* polyps in nasal cavity or the middle meatus, and/or
* radiographic imaging showing inflammation of the paranasal sinuses
Exclusion Criteria:
* Unable to speak English
* History of comorbid ciliary dyskinesia, cystic fibrosis or any other mucociliary condition
* Dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma and chronic obstructive pulmonary disease.
* History of oral or systematic antibiotic use in the past 2 weeks
* History of nasal or sinus surgery within past 6 weeks
* History of cerebrospinal fluid leak
* History of allergy to budesonide or other topical steroids
* Pregnant or breast feeding
* Current infection or history of one of the following infections: Tuberculosis (TB) lung infection, or Herpes infection of the eye.
* Baseline SNOT-22 total scores below 9 were excluded due to the inability to achieve a minimally clinically improved difference
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02696850
Study Brief:
Protocol Section:
NCT02696850