Sensitivity and Specificity of 3 Solutions of Allergen Extract for Diagnosis by Skin Prick Testing
Phase 3
Completed
- Conditions
- Allergy
- Registration Number
- NCT01964768
- Lead Sponsor
- Stallergenes Greer
- Brief Summary
A Phase III study to determine the sensitivity and specificity of three solutions of different allergen extracts for diagnosis by skin prick-test:
* 5 Grasses pollen,
* Birch pollen,
* Dermatophagoides pteronyssinus mite
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 324
Inclusion Criteria
- Written informed consent to participate in the study
- Male or female subjects aged 5-60 years inclusive
- Female of childbearing potential must be on a reliable method of contraception and have a negative urine pregnancy test
- Presence of a clinical history of allergy: seasonal or perennial rhinitis, conjunctivitis and/or asthma during grass or birch pollen seasons (at least two pollen seasons) and/or due to mite exposure (at least two years)
- Subjects affiliated to a social security system
Exclusion Criteria
- Pregnant or breastfeeding women
- Dermographism
- Absence of cutaneous reactivity
- Presence of cutaneous lesions on the forearms either preventing the performance of the test or potentially interfering with the interpretation of the test
- Subjects presenting unstable asthma or poor general health condition
- Subjects with past or current specific immunotherapy treatment for any of the 3 tested allergens (Grass, Birch pollens, D. pteronyssinus and/or D. farinae mites) in the previous 5 years
- Any oral antihistaminic treatment in the previous 3 days or 10 days in case of loratadine or desloratadine
- Subjects on anti-IgE treatment
- Subjects treated with beta-blockers and/or anti-depressives.
- Subjects currently participating in another clinical trial or still in exclusion period for a previous clinical trial
- Investigators, co-investigators, as well as their children or spouses and all the study collaborators
- Subjects under protection of the courts, legal guardianship or legal trusteeship
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Skin wheal measure for each tested solution. For each allergen tested, 2 variables, positive SPT and negative SPT were defined. A SPT reaction was considered positive when the mean wheal diameter was >3 mm. A SPT reaction ≤3 mm was considered negative. For each subject, the study consisted in one visit of about 60 minutes including skin prick-test and collection of blood sample for IgE determination.
- Secondary Outcome Measures
Name Time Method One of the secondary measurement was the wheal diameter for each allergen. SPT measurements were performed after the study visit, an expected average of 1 week.