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Clinical Trials/EUCTR2010-020079-22-FR
EUCTR2010-020079-22-FR
Active, not recruiting
Phase 1

Determination of sensitivity and specificity of five solutions of allergen extract (5 grasses, birch, ragweed pollens and Dermatophagoides pteronyssinus and Dermatophagoides farinae mites) for diagnosis by skin prick testing. - Sensitivity and specificity of solutions for diagnosis by skin prick-test

STALLERGENES S.A.0 sitesMay 11, 2010

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
STALLERGENES S.A.
Status
Active, not recruiting
Last Updated
8 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 11, 2010
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
STALLERGENES S.A.

Eligibility Criteria

Inclusion Criteria

  • 1\. Written informed consent to participate in the study.
  • 2\. Male or female subjects aged 5\-60 years inclusive.
  • 3\. Female of childbearing potential must be on a reliable method of contraception and have a negative urine pregnancy test.
  • 4\. Presence of a clinical history of allergy: seasonal or perennial rhinitis, conjunctivitis and/or asthma during grass, birch or ragweed pollen seasons (at least two pollen seasons) and/or due to mite exposure (at least two years).
  • 5\. Subjects affiliated to a social security system.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range
  • F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

  • 1\. Pregnant or breastfeeding women.
  • 2\. Dermographism.
  • 3\. Absence of cutaneous reactivity
  • 4\. Presence of cutaneous lesions on the forearms either preventing the performance of the test or which may interfere with the interpretation of the test.
  • 5\. Subjects presenting unstable asthma or poor general health condition.
  • 6\. Subjects with past or current specific immunotherapy treatment for any of the
  • 5 tested allergens (Grass, Birch, Ragweed pollens, D. pteronyssinus and D. farinae mites) in the previous 5 years.
  • 7\. Any oral antihistaminic treatment in the previous 3 days or 10 days in case of loratadine or desloratadine.
  • 8\. Subjects on anti\-IgE treatment.
  • 9\. Subjects treated with ß\-blockers and/or anti\-depressives.

Outcomes

Primary Outcomes

Not specified

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