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 @ 12:43 PM
Ignite Modification Date:
2025-12-24 @ 12:43 PM
NCT ID:
NCT06574061
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 5 years or older
* Patients with a respiratory allergy with significant clinical symptoms and whose diagnosis was confirmed by a positive skin prick-test and/or the presence of specific IgE antibodies to one or more allergens implicated in the symptoms
* Patients eligible for AIT (patients who had been treated with AIT in the 3 years prior to the inclusion visit could be included if starting a new form and/or type of AIT)
* Patients previously treated with a pharmacological AR treatment in the month before the inclusion visit or during the previous pollen season, and requiring the initiation of AIT
* Patients (and/or their parents or legal representatives as appropriate) agreeing to take part in the study after having been informed orally and in writing by the observing physician.
Exclusion Criteria:
* Patient with a hypersensitivity (allergy) to any of the excipients in the selected AIT
* Patients taking beta-blockers (including local treatments, e.g. eye drops)
* If asthmatic patient:
* Patients with uncontrolled (unstable) or severe asthma (in adults this was defined as daily symptoms and FEV1 \<70% of the theoretical value after appropriate drug treatment, and in children and adolescents by FEV1 \<80% of the theoretical value after appropriate drug treatment)
* Patients who have had a severe asthma exacerbation in the last three months
* Asthmatic patient with unresolved acute infection of the airways.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT06574061
Study Brief:
Protocol Section:
NCT06574061