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 @ 11:49 AM
Ignite Modification Date:
2025-12-24 @ 11:49 AM
NCT ID:
NCT01166061
Eligibility Criteria:
Inclusion Criteria:
* Male or female, aged 18-65 years
* Minimum 2 year history of rhinoconjunctivitis on exposure to grass
* Positive skin prick test to whole grass allergen
* LPSR to whole grass allergen 8-10 hours after intradermal injection of greater than 35mm diameter response
* Positive CPT to whole grass allergen with a score ≥4
Exclusion Criteria:
* Subjects with a history of asthma
* Subjects with an FEV1 \<80% of predicted
* Subjects with a rye grass specific IgE \>100 kU/L
* Subjects with an acute phase skin response to whole grass allergen with a mean wheal diameter \> 50 mm
* Subjects who score \>1 for redness of conjunctiva or who have any watering or itchiness in the eye before administration of the CPT
* Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquillisers or psychoactive drugs
* History of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01166061
Study Brief:
Protocol Section:
NCT01166061