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

NCT01964768 | Completed Phase 3

• 1 other identifier: DG40.08
• Study Type: interventional
• Target: 324
• Locations: 0 countries
• Sites: N/A

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

Conditions

Allergy

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Other Outcomes (1)

• 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.

Interventions

Skin prick-test OTHER

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Stallergenes Greer: lead

MeSH Terms

Conditions

Hypersensitivity

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Frédéric de Blay, Pr

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 17, 2013
• Study Start: December 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: February 1, 2012
• Last Updated: October 17, 2013

Record last verified: 2013-10