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 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT00150761
Eligibility Criteria:
Inclusion Criteria:
* Healthy male Caucasian subject aged between 18 and 55 years (both inclusive).
* Subject must have a positive prick test to histamine (wheal diameter ≥ 6 mm with histamine dihydrochloride (100 mg/mL) and ≤ 3 mm with diluent control).
Exclusion Criteria:
* History of allergic disease, documented or suspected, including but not limited to: asthma, whether or not considered as allergic; nocturnal cough episode suspected to be of asthma-equivalent nature (three or more consecutive nights resulting in sleep disturbances) ; allergic rhinitis, conjunctivitis or sinusitis; nasal polyposis; dermatitis of the face or neck; drug or food allergy.
* Any clinically significant vascular disease such as hyper- or hypotension, venous disorder, vasculitis etc.
* History of hot flushes and any other vasomotor disorders.
* ENT infection or Upper Respiratory Tract Infection not completely cured at least one week before inclusion.
* Any known history of laryngeal edema.
* Nasal structural abnormalities (e.g. deviation of the nasal septum…).
* Recent immunotherapy
* Skin irritants or UV exposure 48 hours before each visit.
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00150761
Study Brief:
Protocol Section:
NCT00150761