NCT Number: NCT01964768
Sensitivity and Specificity of 3 Solutions of Allergen Extract for Diagnosis by Skin Prick Testing
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
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Notify MeKey information
Conditions
Age range
5 year–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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.
Time frame: 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
-
One of the secondary measurement was the wheal diameter for each allergen.
Time frame: SPT measurements were performed after the study visit, an expected average of 1 week.
Other outcomes
-
The secondary measurement was also the specific IgE level for each allergen.
Time frame: Specific IgE results were known after the study visit, an expected average of 3 days.
Sponsors and collaborators
Lead sponsor
Stallergenes Greer
Industry
Registry information
Official study 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
Important dates
- Study start
- 2010
- Primary completion
- 2011
- Study completion
- 2012
- First posted
- Oct 17, 2013
- Registry last updated
- Oct 17, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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