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 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT02079792
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 19 years and older.
* Diagnosed with CRS according to the Canadian Practice Guidelines for Acute and Chronic Rhinosinusitis2.
* Having previously received complete bilateral FESS, which includes uncinectomy, anterior and posterior ethmoidectomy, maxillary antrostomy, sphenoidotomy and frontal sinusotomy, at least 3 months prior to receiving the study intervention.
* Individuals presenting with sinonasal mucosal edema that warrant treatment with nasally administered Budesonide.
Exclusion Criteria:
* Patients unable to speak, read, or write English.
* Females who are pregnant.
* Presenting with septal deviations and/or perforations.
* Patients already taking oral or topical steroids at the time of enrollment 3-months post-FESS
* Prior history of facial trauma or presenting with anatomical abnormalities that may affect spray distribution. Abnormalities can include middle turbinate lateralization, and/or previously resected middle or inferior turbinates..
* Previous history of extensive sinus surgery (e.g. open sinus surgery, endoscopic endonasal tumor resection, modified Lothrop procedure).
* Patients unable to physically orient themselves in either study position due to severe obesity or joint/muscle pain.
* Cystic fibrosis, primary ciliary dyskinesia patients, diabetes, or hypertension.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02079792
Study Brief:
Protocol Section:
NCT02079792