Clinical trial NCT01964768: Sensitivity and Specificity of 3 Solutions of Allergen Extract for Diagnosis by Skin Prick Testing
Official title: Determination of Sensitivity and Specificity of Three Solutions of Allergen Extract (5 Grasses, Birch Pollens and Dermatophagoides Pteronyssinus Mites) for Diagnosis by Skin Prick Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 324
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 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 outcomes:
measure: One of the secondary measurement was the wheal diameter for each allergen.
timeFrame: SPT measurements were performed after the study visit, an expected average of 1 week.
Other outcomes:
measure: The secondary measurement was also the specific IgE level for each allergen.
timeFrame: Specific IgE results were known after the study visit, an expected average of 3 days.
Locations:
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France
name: Frédéric de Blay, Pr
role: PRINCIPAL_INVESTIGATOR
References: