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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT00425620
Eligibility Criteria:
Inclusion Criteria:
* Has a diagnosis of refractory, postsurgical chronic sinusitis
* Has a documented history of chronic sinusitis symptoms for more than 12 weeks
* A CT scan showing a certain level of mucosal thickening in at least 1 maxillary sinus
* An endoscopy documenting the presence of inflammation and absence of stage 4 polyps
* Ability to comply with the study requirements including the ability to administer a nasal lavage twice daily for 4 months
* Females of childbearing potential must use adequate birth control methods and not plan to get pregnant during the course of the study.
* Ability to read or speak English
Exclusion Criteria:
* Has a hypersensitivity to Amphotericin B or the compounds of any study medications
* Is an immunosuppressed patient or is receiving disease modifying agents
* Has an acute upper or lower respiratory illness
* Has an acute exacerbation of chronic sinusitis within 1 month prior to randomization
* Has used systemic antibiotic therapy for reasons other than acute sinusitis within 3 weeks prior to randomization
* Has used any antibiotic therapy for acute complication of chronic sinusitis within 1 month prior to randomization
* Has orbital or central nervous system complications
* Has acute asthma at study initiation
* Began using nasal corticosteroids or had a dosage change within 3 months prior to randomization
* Has taken a dose of oral or intravenous steroids to treat any condition other than asthma within 1 month prior to randomization
* Has used any systemic antifungal therapy within 3 months prior to randomization
* Has used intranasal antifungal therapy for chronic sinusitis within 3 months prior to randomization
* Currently has a clinically significant deviated nasal septum that has not been remedied by surgery
* Has an anatomical abnormality which would significantly obstruct the nasal passages
* Has cystic fibrosis
* Is pregnant
* Has stage 4 polyposis
* Has any significant medical condition that in a doctor's opinion could affect the patient's participation in the trial
* Has used any investigational product within 1 month of study initiation
* Has a history of cancer other than treated squamous cell or basal cell carcinoma of the skin that has not been in full remission for at least 5 years prior to study initiation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT00425620
Study Brief:
Protocol Section:
NCT00425620