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

October 14, 2013 updated by: Stallergenes Greer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

324

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Outcome Measures

Outcome Measure
Time Frame
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.
SPT measurements were performed after the study visit, an expected average of 1 week.

Other Outcome Measures

Outcome Measure
Time Frame
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.
Specific IgE results were known after the study visit, an expected average of 3 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stallergenes Greer

Investigators

  • Principal Investigator: Frédéric de Blay, Pr, Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

October 10, 2013

First Submitted That Met QC Criteria

October 14, 2013

First Posted (ESTIMATE)

October 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 17, 2013

Last Update Submitted That Met QC Criteria

October 14, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DG40.08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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