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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT01634958
Eligibility Criteria:
Inclusion Criteria:
* appropriately signed and dated ICON prior to study specific action
* IgE-mediated Sensitization against grass pollen
* Perception of disease activity of at least 30 mm on a 100 mm VAS
* FEV1 or a PEFR value \> 80% of predicted normal value
* Allergic rhinitis and/or rhinoconjunctivitis symptoms (at least 2 years) with or without intermittent asthma symptoms verified by:
* suggestive medical history AND
* specific IgE against grass pollen with CAP-RAST ≥ 2 AND
* a positive SPT (wheal diameter ≥ 3 mm) AND
* a positive CPT for grass pollen
* Patients with co-allergies are allowed to enter the study:
* being asymptomatic against co-allergens such as tree or weed pollen, house dust mites, cat and dog, and other country specific allergens
* with CAP-RAST co-allergen \< grass (detailed specifications given for Birch, HDM, animal dander, other country specific allergens)
* All other co-allergens: difference in CAP RAST co-allergen to grass of ≥ 2 and an SPT wheal diameter co-allergen \< grass
* Females of non-childbearing potential must be postmenopausal for at least
1 year or surgically sterilized
* Females of childbearing potential must be non-lactating, non-pregnant and must correctly use an effective method of contraception during the study.
Exclusion Criteria:
* Acute or chronic infectious conjunctivitis
* History of significant clinical manifestations of allergy as a result of sensitisation against trees or weed pollen and perennial allergens (e.g., house dust mites)
Patients are not allowed to enter into the study:
* with typical symptoms against co-allergens such as tree or weed pollen, HDM, cat and dog, and other country specific allergens
* with CAP-RAST co-allergen ≥ grass
* Persistent asthma, according to Global Initiative for Asthma (GINA)
* Acute or chronic inflammatory or infectious airways disease
* Chronic structural disease of the lung (e.g., emphysema or bronchiectasis)
* Autoimmune and/or immune deficiency
* Any disease that prohibits the use of adrenaline (e.g., hyperthyroidism)
* Severe uncontrolled disease that could increase the risk to the patients while participating in the study, including but not limited to: cardiovascular insufficiency, severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disorders.
* Active malignant disease during the previous 5 years
* Significant abnormal laboratory parameter or alteration in vital signs that could increase the risk to the study patient
* Abuse of alcohol, drugs or medications within the past year
* Severe psychiatric, psychological or neurological disorder
* Immunotherapy against grass pollen within the last 5 years
* Systemic and/or topical treatment with β-blockers within 1 wk prior to V2
* Use of medication that may interfere with the immune system or has been using any medication which might still have an influence on the immune system at V2
* Use of tranquiliser or psychoactive drugs within 1 week prior to V1
* Use of systemic corticosteroids within 3 months prior to V1
* Immunization with vaccines within 7 days prior to V2
* Expected non-compliance and/or no cooperation
* Participation in another clinical study within 30 days prior to V2
* Prior participation in this study
* Employees at the investigational centre or first degree relative or partner of the investigator
* Planed donation of germ cells, blood, organs or bone marrow during the course of the study
* Contractually not capable
* A positive pregnancy test at V1
* Jurisdictional or governmentally institutionalised.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01634958
Study Brief:
Protocol Section:
NCT01634958