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 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 12:11 AM
NCT ID:
NCT04531358
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent obtained before any trial related procedures are performed
* Healthy male or female subjects aged 18 to 65 years
* A documented clinically relevant allergic history of moderate to severe SAR to grass pollen for the previous two years
* Subjects exhibit a moderate to severe response to approximately 1500 grass pollen grains/m3 within the first 2 hours in the Vienna Challenge Chamber, which is defined as total nasal symptom score (TNSS) of at least 6 (out of 12) using standard VCC grass pollen allergen mixture. Nasal symptom score is the sum of "nasal congestion", "rhinorrhea", "itchy nose" and "sneezing", each of which have been scored on a categorical scale from 0 to 3.
* Positive Skin Prick Test (SPT) response (wheal diameter at least 3 mm larger than diluent control) to grass pollen SPT solutions (standard Allergopharma) at screening or within the last 12 months prior to study start.
* Positive serum specific IgE against recombinant major allergen components of the used grass pollen e.g. g6 (specific CAP IgE ≥0.70 kU/L) at screening or within the last 12 months prior to study start.
* Asthma patients only if the asthma condition is mild or intermittent, and if those are not treated with steroids
* Subject has a forced expiratory volume in 1 second (FEV1) of at least 80% of predicted value (ECCS) at the screening.
* Subject is capable of understanding the study procedures and potential risks associated with the study, and voluntarily agrees to participate by giving written informed consent.
* Subject is able to adhere to dose and visit schedules.
* Subject is able to read, understand and
Exclusion Criteria:
* A clinical history of uncontrolled asthma within 3 months prior to screening
* Subjects with asthma requiring treatment with inhaled corticosteroids on a regular basis judged by the investigator
* Previous successful immunotherapy to grass pollen, a grass pollen allergen or a cross-reacting allergen within the past 3 years
* Ongoing treatment with any allergen-specific immunotherapy product
* Subjects with history of tuberculosis
* Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomization
* Clinically relevant nasal polyps, medical history of paranasal sinus surgery and/or medical history of surgery of nasal turbinates judged by the investigator
* Subjects using any ophthalmic steroids during the last 30 days
* Subjects treated with nasal, inhaled or systemic steroids during the last 30 days
* History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise induced, food allergy, drugs or an idiopathic reaction)
* Any clinically relevant chronic disease judged by the investigator
* Systemic disease affecting the immune system judged by the investigator
* Use of an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
* History of allergy, hypersensitivity or intolerance to any ingredients of the study medication
* History of alcohol or drug abuse.
* Being immediate family of the investigator or trial staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild
* Subjects treated with leukotriene antagonists (1 month before study start), long- lasting anti-histamines, like cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine (5 to 10 days before study start), mast cell stabilizer (2 weeks before study start) or nasal decongestant (3 days before study start)
* Subjects with an acute or chronic sinusitis judged by the investigator
* Positive Serology result judged by the investigator
* Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted and s
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04531358
Study Brief:
Protocol Section:
NCT04531358