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

Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964768
• Other study ID #: DG40.08
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2013
• Last updated: October 14, 2013
• Start date: December 2010
• Est. completion date: February 2012

Study information

• Verified date: October 2013
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: February 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 60 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Allergy

Intervention

Other:
• Skin prick-test

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stallergenes

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The secondary measurement was also the specific IgE level for each allergen.		Specific IgE results were known after the study visit, an expected average of 3 days.	Yes
Primary	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.	Yes
Secondary	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.	Yes