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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT03928561
Eligibility Criteria:
Inclusion Criteria:
* Controlled intermittent asthma (step 1 treatment, according to GINA Guideline 2016) with or without association with cat allergy related rhino-conjunctivitis;
* Sensitization to cat allergen extract as defined by skin prick test for cat extract with a wheal diameter of ≥3 mm greater than negative control (ALK, HØrsholm, Denmark) and specific IgE anti Fel d 1 ≥ 0.7 kU/L ( ImmunoCAP, Thermofisher, Uppsala, Sweden);
* FEV1 ≥ 70% of the predicted value;
* No cat exposure at home or outside of the home during the study;
* Positive methacholine challenge test performed using an AeroDoseur DTF-Atomisor ATO-AD 12 (Saint-Etienne, France);
* Early asthmatic response during baseline cat allergen exposure.
Exclusion Criteria:
* Uncontrolled asthma, asthma control test inferior to 20 within the 4 weeks preceding the study.
* Uncontrolled asthma 2 weeks after stopping LABA treatment.
* LABA treatment within the 2 weeks preceding the study.
* Severe asthma (\> GINA 2)
* Subject lives with a cat
* Cat desensibilisation within the 6 previous months.
* Active smoker
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03928561
Study Brief:
Protocol Section:
NCT03928561