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 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT01445002
Eligibility Criteria:
Inclusion Criteria:
* History of seasonal allergic rhinitis from grass pollen
* Normal electrocardiogram
* Moderate to severe response to approx. 1500 grass pollen grains/m3 after 2 hrs of exposure in challenge chamber
* Positive skin prick test for grass pollen at or within 12 months preceding screening visit
* Positive RAST (class 2 or higher) for timothy grass pollen and to rPhl p 1 + rPhl p 5 at or within 12 months preceding screening visit
Exclusion Criteria:
* Pregnant or lactating females
* Females with childbearing potential not using medically acceptable birth control
* Structural nasal abnormalities, nasal polyposis, history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection
* Any respiratory disease other than mild asthma controlled with occasional short acting beta agonists and normal lung function
* Current or recent participation in another clinical trial
* SIT for grass pollen allergy in the last two years prior to study
* Past or present disease, which may affect outcome of the trial, judged by investigator
* Autoimmune diseases, immune defects including immunosuppression, immune- complex immunopathies
* Suspected hypersensitivity to any ingredients of study medication
* Use of prohibited medication prior to screening and throughout study
* depot corticosteroids (12 weeks)
* oral corticosteroids (8 weeks)
* inhaled corticosteroids (4 weeks)
* Allergic symptoms at the time of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01445002
Study Brief:
Protocol Section:
NCT01445002