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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT00825656
Eligibility Criteria:
Inclusion Criteria:
* Willing to participate as indicated by providing written informed consent
* 12 years of age or older, of any gender and any race
* Have had a positive skin prick and/or intradermal test for a currently prevalent allergen within the past 5 years
* A history of allergic rhinitis, for at least 2 years
* Have undergone washout of all medications that could have an influence on the study
* Willing and able to make required study visits
* Able to follow instructions and record diary symptoms.
* Free of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination
* Have a TNSS between 4 and 12 averaged over the 7 days immediately prior to V2
* Have an average individual score for nasal congestion greater than or equal to 2 over the 7 days immediately prior to V2.
Exclusion Criteria:
* any concurrent disease that could interfere with the investigation or evaluation of the study medications such as: rhinitis medicamentosa or large obstructive nasal polyps
* any other anatomic nasal deformity that could interfere with their participation in the study
* asthma, with the exception of mild intermittent asthma
* congestion that, in the opinion of the study investigator, could interfere with successful nasal drug administration/absorption (in either nostril)
* use of systemic corticosteroids (oral, parenteral, intravenous, rectal) or inhaled or ocular corticosteroids within the last 30 days
* be undergoing allergy immunotherapy, unless on a stable dosing regimen throughout the course of the study
* Be using dermal potent or super-potent topical corticosteroids
* any systemic disorder that could interfere with the evaluation of the study medication
* hypersensitivity to the study drugs or any component thereof
* history of drug or alcohol abuse that would interfere with participation in the study
* history of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses that could be expected to interfere with the study
* upper or lower respiratory infection within 14 days of Vist 2
* acute sinusitis within 30 days of Visit 2
* any history or evidence of nasolacrimal drainage system malfunction
* Be planning to travel to an area significantly antigenically different for a substantial portion (more than 48 hours) of any given study week.
* participation in any other investigational study within 30 days before entry into this study or concomitantly with this study
* chronic or intermittent use of any prescription or over-the-counter (OTC) nasal spray during the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00825656
Study Brief:
Protocol Section:
NCT00825656