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 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT01279057
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant, non-lactating female 12 years of age or older with a minimum of 2 years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
* Signed informed consent (assent) form.
* Documented positive allergic skin test to local pollen.
* An average score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum score of at least 2 for "nasal congestion" and at least 4 on the reflective Total Ocular Symptom Score (rTOSS).
Exclusion Criteria:
* History of asthma that required chronic therapy (with the exception of occasional acute or mild exercise induced asthma).
* Some other past and concomitant medical conditions, prohibited medications.
* Upper respiratory tract infection or any untreated infections.
* Patient has started immunotherapy/changed the dose.
* Any known allergy to any of the components of the study nasal spray.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01279057
Study Brief:
Protocol Section:
NCT01279057