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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT01223820
Eligibility Criteria:
Inclusion Criteria:
1. Patients with persistent (\> 12w) rhinological symptoms: nasal discharge, sneezing, congestion for an average of at least 1 h per day for at least 5 days during a period of 14 days, negative skin prick test or negative RAST, and without structural abnormalities explaining nasal obstruction will be proposed to participate in the trial.
2. Age \> 18 and \< 50 years
3. Written informed consent
4. Willingness to adhere to visit schedules
5. Adequate contraceptive precautions in female patients with childbearing potential
6. Unresponsiveness to nasal steroid spray (4 weeks of use)
Exclusion Criteria:
1. Age \< 18 and \> 50 years
2. Patients with AR, demonstrated by either positive skin prick test or RAST
3. Presence of IgE in nasal lavage fluid
4. Structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall.
5. Systemic steroid treatment less than 4 weeks before the inclusion in the study.
6. Nasal steroid spray less than 4 weeks before the inclusion, oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion.
7. Inability of the patient to stop taking medication affecting nasal function.
8. Evidence of infectious rhinitis/rhinosinusitis.
9. Pregnancy or breastfeeding.
10. Any disorder of which might compromise the ability of a patient to give truly informed consent for participation in this study.
11. Enrollment in other investigational drug trial(s) or is receiving other investigational agent(s) for any other medical condition.
12. Contra-indications for local anaesthesia (Cocaïne 5%).
13. Smoking.
14. Systemic disease with lesions in ENT domain.
15. Malignancies or severe comorbidity.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01223820
Study Brief:
Protocol Section:
NCT01223820