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:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT01616160
Eligibility Criteria:
Inclusion Criteria:
\- The subject must fulfill all of the following conditions or characteristics to be considered for enrollment:
1. Male or female between ages 21 - 70 years residing in the Boston area
2. History of chronic rhinosinusitis (symptoms for at least 3 months). Subject must have two or more of the following:
* Facial pain/pressure or headache
* Nasal congestion
* Anterior or posterior nasal drainage
* Hyposmia/anosmia
3. Abnormal CT scan in at least 2 sinuses areas within 3 months
4. Evidence of bilateral polyps or polypoid mucosa (on nasal endoscopy) with minimum polyp/polypoid score of 4 (see scoring system below).
Exclusion Criteria:
* 4\. History of suggestive of immunodeficiency (i.e. those who have had \> one pneumonia in the past 12 months or those with known immune deficiency).
5. History of cystic fibrosis, Kartagener's syndrome, immotile cilia syndrome, hypogammaglobulinemia or bleeding disorder
6. URI within six weeks prior to enrollment
7. Intranasal cocaine use
8. Pregnancy (if applicable
9. History of fainting
MEDICATION EXCLUSIONS prior to NP biopsies:
10. Use of prescription blood thinners
11. Use of systemic glucocorticoids for two weeks prior to enrollment
12. Use of intranasal corticosteroids and anticholinergics for three days prior to enrollment
13. Use of an antibiotic for three days prior to enrollment
14. Use of antihistamines for one week prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT01616160
Study Brief:
Protocol Section:
NCT01616160