Sensitivity and Specificity of 3 Solutions of Allergen Extract for Diagnosis by Skin Prick Testing

Stallergenes Greer

Status and phase: Completed; Phase 3

Conditions: Allergy

Treatments: Other: Skin prick-test

Study type: Interventional

Funder types: Industry

Identifiers

NCT01964768

DG40.08

Details and patient eligibility

About

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

Enrollment: 324 patients

Sex: All

Ages: 5 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind