Back to resultsGlycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).
Primary Purpose
Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Standardization of allergenic extract (Gly. domesticus)
Sponsored by
About this trial
This is an interventional diagnostic trial for Rhinitis, Allergic, Seasonal focused on measuring Allergen extract Standardization
Eligibility Criteria
Subject inclusion criteria:
- A documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to Glycyphagus domesticus.
- Positive skin prick test with an available preparation of the same allergen extract (a wheal major diameter of at least 3 mm) and/or a positive test for specific IgE.
- Mean of the areas of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 7 mm2.
- Age ≥ 18 years and ≤ 50 years
- Subject can be male or female
- Subject must be capable of providing written informed consent
Subject exclusion criteria:
- Subjects should not be excluded due to low or high sensitivity to Glycyphagus domesticus.
- Immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested.
- Use of drugs that may interfere with the skin reactions.
- Pregnancy, dermographism, atopic dermatitis (locally at the test site), urticaria.
- Any disease which prohibits the use of adrenaline (hyperthyroidism, arterial hypertension, cardiopathy, etc.)
- Lack of cooperation which may interfere with the study, or subjects with severe psychiatric, psychological or neurological disorders.
Sites / Locations
- Clinica Dr. Lobatón
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Four concentrations of Glycyphagus domesticus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, was tested in every patient in duplicate on the volar surface of the forearm.
Outcomes
Primary Outcome Measures
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00917488
Brief Title
Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).
Official Title
Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Laboratorios Leti, S.L.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of the trial is to prove the therapeutic value of the product and enable an effective and safe dosage schedule to be recommended
Detailed Description
The objective of this study is to determine the biologic activity of a Glycyphagus domesticus allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
The skin testing procedure, based on the Nordic Guidelines is the reference method for the biological calibration of in-House Reference Preparations (IHRP). The method is not intended for routine testing of allergen extracts. The use of this procedure is the basis for the definition of biological activity units: "the activity of an allergen extract is 10,000 Biological Units (BU) per ml (10 HEP per ml), when the extract provokes an specific skin reaction in the median sensitive patient with a wheal of the same size as a wheal provoked by a positive reference solution consisting of histamine 54.3 mmol/l (for example histamine dihydrochloride 10 mg/ml), when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are clinically allergic and cutaneously reactive to the allergen concerned".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic
Keywords
Allergen extract Standardization
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Four concentrations of Glycyphagus domesticus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, was tested in every patient in duplicate on the volar surface of the forearm.
Intervention Type
Other
Intervention Name(s)
Standardization of allergenic extract (Gly. domesticus)
Intervention Description
Allergenic extract for cutaneous prick-test
Primary Outcome Measure Information:
Title
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
Time Frame
45 minutes per subject
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Subject inclusion criteria:
A documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to Glycyphagus domesticus.
Positive skin prick test with an available preparation of the same allergen extract (a wheal major diameter of at least 3 mm) and/or a positive test for specific IgE.
Mean of the areas of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 7 mm2.
Age ≥ 18 years and ≤ 50 years
Subject can be male or female
Subject must be capable of providing written informed consent
Subject exclusion criteria:
Subjects should not be excluded due to low or high sensitivity to Glycyphagus domesticus.
Immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested.
Use of drugs that may interfere with the skin reactions.
Pregnancy, dermographism, atopic dermatitis (locally at the test site), urticaria.
Any disease which prohibits the use of adrenaline (hyperthyroidism, arterial hypertension, cardiopathy, etc.)
Lack of cooperation which may interfere with the study, or subjects with severe psychiatric, psychological or neurological disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Moreno, MD, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica Dr. Lobatón
City
Cádiz
State/Province
Cadiz
ZIP/Postal Code
11008
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).
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