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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT01523158
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Age 18 with no upper age limit
* History of seasonal rhino-conjunctivitis in the appropriate season, not controlled by optimised standard medical therapy
* Positive skin prick test to grass pollen or tree pollen
Exclusion Criteria:
* Inadequately controlled or moderate to severe asthma (GINA III/IV), i.e. the FEV1 is below 70 % of the target value despite adequate pharmacotherapy
* Irreversible changes in the reaction organ (emphysema, bronchiectasis, etc.)
* Clinically significant cardiovascular insufficiency (in cardiovascular diseases, there is an elevated risk of adverse reactions to adrenaline)
* Local or systemic use of beta blockers
* Diseases of the immune system (autoimmune diseases, immune complex-induced immunopathies, immunodeficiencies etc.)
* Malignant disease within the past five years (Patients with previous malignant disease that is considered cured may be included subject to the consent of their oncologist)
* Inability to attend regularly for injections and follow-up visits
* Severe atopic dermatitis
* Pregnant or not using adequate contraception (post-menopausal, surgically sterilised, long-term abstinent, or barrier methods plus spermicide)
* Breast-feeding
* Evidence of current drug or alcohol misuse
* Hypersensitivity to any of the SIT (immunotherapy product) excipients
* Active tuberculosis
* Severe mental disorders
* Multiple sclerosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01523158
Study Brief:
Protocol Section:
NCT01523158