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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT01430260
Eligibility Criteria:
Inclusion Criteria:
* Allergic rhinitis patients aged ≥ 18 years (with a history of AR of 1 years or longer)
* Moderate to severe patient according to ARIA guideline
* To have a demonstrated positive skin prick test or other serologic tests to at least 1 allergen.
* Subjects who complete the subject diary(S) at least 70%.
Exclusion Criteria:
* Nasal pathology, including nasal polyps, clinically relevant respiratory tract malformations, recent nasal biopsy (within 60 days), nasal trauma, nasal surgery, atrophic rhinitis, rhinitis medicamentosa (within 60 days), asthma requiring corticosteroid treatment
* Hypersensitivity to corticosteroid and/or hydroxyzine
* Hypersensitivity to galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
* A history of respiratory tract infection or disorder within 2 weeks of the screening visit or had a respiratory tract infection during baseline
* Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of β-agonists
* Treated with systemic corticosteroids (within 8 weeks of study initiation) or topical corticosteroids (\> 1% hydrocortisone, within 4 weeks of study initiation) or antibiotics (within 2 weeks of first visit)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01430260
Study Brief:
Protocol Section:
NCT01430260