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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT06104293
Eligibility Criteria:
Main Inclusion Criteria:
* Subjects with symptoms of allergic rhinoconjunctivitis to grass pollen without associated asthma, requiring anti-allergic treatment for at least 2 consecutive pollen seasons;
* Subjects with positive skin prick tests to grass pollen extracts (Phleum pratense): papule diameter ≥ 5 mm compared to the negative control (NaCl reaction \< 2 mm));
* Subjects with Phl p 5 specific recombinant Immunoglobulin E ≥ 0.70 kIU/L;
* Forced expiratory volume in 1 second (FEV1) ≥ 70% of predicted value at screening and before allergenic exposures;
* Women of childbearing age must have a negative pregnancy test at screening and before exposure visits;
Main Exclusion Criteria:
* Specific immunotherapy (SIT) to grass pollen allergens for more than one month in the 3 years preceding the screening visit;
* Ongoing specific immunotherapy to another allergen
* History of anaphylaxis following exposure to grass pollen or grass SITs;
* Asthma
* Ear, Nose \& Throat or ocular surgical intervention in the 6 months preceding inclusion;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06104293
Study Brief:
Protocol Section:
NCT06104293