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

NCT ID: NCT01964768

Last Updated: 2013-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-02-29

Brief Summary

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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

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Conditions

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Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Skin prick-test

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stallergenes Greer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric de Blay, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France

Other Identifiers

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DG40.08

Identifier Type: -

Identifier Source: org_study_id