- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00718744
Standardization of Chortoglyphus Arcuatus Allergenic Extract. Determination of Biological Activity in HEP Units
August 4, 2010 updated by: Laboratorios Leti, S.L.
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
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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".
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lugo
-
Calde, Lugo, Spain, 27004
- Hospital "Xeral de Calde"
-
-
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
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Voluntarily signed informed consent form by the patient
- Patients should live in a geographic zone where allergy caused by Chortoglyphus arcuatus is a relevant problem.
- Patients should not be excluded due to low or high sensitivity to the allergen, when they otherwise fulfil the inclusion criteria.
- A positive case history with inhalant allergy related to exposure to the allergen to be tested.
- A positive prick test (mean wheal diameter > 3 mm) when tested with a standardized extract prepared from the allergen source in question and/or a positive test for specific IgE.
- A mean wheal diameter > 7 mm2 obtained in a prick test with histamine dihydrochloride 10 mg/ml.
- Age: 18-50 years.
- Both genders
Exclusion Criteria:
- 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.
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
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
In each individual patient, 10 mg/ml histamine dihydrochloride solution and a phenolated saline solution will be applied as positive and negative control respectively.
|
Allergenic extract for cutaneous prick-test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Wheal size area (mm2) of the immediate phase reaction.
Time Frame: 30 minutes per subject
|
30 minutes per subject
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Manuel Boquete, MD
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
June 1, 2008
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
July 17, 2008
First Submitted That Met QC Criteria
July 17, 2008
First Posted (Estimate)
July 21, 2008
Study Record Updates
Last Update Posted (Estimate)
August 5, 2010
Last Update Submitted That Met QC Criteria
August 4, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Conjunctival Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Conjunctivitis
- Conjunctivitis, Allergic
Other Study ID Numbers
- 2005-001194-96
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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