search
Back to results

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

Primary Purpose

Allergy

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Skin prick-test
Sponsored by
Stallergenes Greer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Allergy

Eligibility Criteria

5 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    One of the secondary measurement was the wheal diameter for each allergen.

    Full Information

    First Posted
    October 10, 2013
    Last Updated
    October 14, 2013
    Sponsor
    Stallergenes Greer
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01964768
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    February 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stallergenes Greer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantInvestigator
    Allocation
    N/A
    Enrollment
    324 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Skin prick-test
    Primary Outcome Measure Information:
    Title
    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 Outcome Measure Information:
    Title
    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 Pre-specified Outcome Measures:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frédéric de Blay, Pr
    Organizational Affiliation
    Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs