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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT00924404
Eligibility Criteria:
We now have two arms to this study.
Group I: Immunocompetent subjects with chronic rhinosinusitis
Inclusion Criteria:
* 56 Adult subjects (18 or older) presenting to the ENT(ears, nose, throat) clinics who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:
* Anterior and/or posterior mucopurulent drainage
* Nasal obstruction
* Facial pain, pressure, and/or fullness
* Decreased sense of smell
* In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.
Exclusion Criteria:
* Cystic fibrosis
* Fungal sinusitis
* Immunocompromised status (use of long term oral steroids (\> 30 days), AIDS, active malignancy or chemotherapy)
* Known Ciliary disorders
* Sinonasal tumors
* Pregnancy
Group 2: CRS with antibody deficiency
* 56 Adult subjects (18 or older) presenting to the Allergy clinic who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:
* Anterior and/or posterior mucopurulent drainage
* Nasal obstruction
* Facial pain, pressure, and/or fullness
* Decreased sense of smell
* In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.
Exclusion criteria:
Cystic Fibrosis Sinonasal tumors Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00924404
Study Brief:
Protocol Section:
NCT00924404