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 @ 10:09 PM
Ignite Modification Date:
2025-12-24 @ 10:09 PM
NCT ID:
NCT01350635
Eligibility Criteria:
Inclusion Criteria:
* Positive history of grass pollen allergy and positive skin prick test reaction to grass pollen extract
* Age between 18 and 60 years
* Subjects must have a standard health care insurance
* Subject must appear capable to understand and comply with all relevant aspects of the study protocol
Exclusion Criteria:
* pregnancy or breast feeding
* autoimmune diseases, immune defects including immuno- suppression, immune-complex-induced immunopathies
* contra-indication for adrenaline
* severe general maladies, malignant diseases
* patients under long-term treatment with systemic corticosteroids, immunosuppressive drugs, tranquilizers or psychoactive drugs
* contra-indications for skin prick testing such as: skin inflammation in the test area, urticaria facticia, unstable or uncontrolled bronchial asthma (30)
* use of beta-blockers
* participation in another clinical trial within one month prior to the study; however, participation during the previous month solely in the form of blood donation without other interventions will be acceptable
* risk of non-compliance with the study procedure and restrictions
* use of oral H1 antihistamines within the previous 3 days, oral Ketotifen within the previous 5 days and topical corticosteroids in the test area within the previous 14 days.
* systemic (short-term) corticosteroids within the previous 14 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01350635
Study Brief:
Protocol Section:
NCT01350635