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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
177
1 country
7
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2012
Actual (reported)Study Completion
November 2012
Actual (reported)Allergen extracts are complex mixtures of proteins and contain varying amounts of allergenic and non-allergenic components. Many factors such as the biovariability, differences in extraction process and subsequent handling of allergens can affect the final composition, potency, and stability of allergen preparations. Genetic diversity of affected people adds another level of complexity. In order to control variability and to achieve consistency and reproducibility for optimal safety and sensitivity/specificity, it is essential to standardize the amount of allergen used in prick tests. Therefore, the system for biological standardization mainly used in Europe still is the biological calibration of in-House Reference Preparations (IHRP). The method has been adopted by the Nordic Council on Medicines as the Nordic Biological Unit, Histamine Equivalent Potency (HEP) or Skin Prick Test (SPT) value. The aim of this procedure is to estimate the biological activity of allergen extracts. The activity of an allergen extract is defined as 1 SPT per ml, when the extract provokes a specific skin reaction with a wheal of the same size as a wheal provoked by reference histamine at a concentration of 10 mg/ml, when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are sensitized to the allergen concerned. The present study aims to standardize the allergen extracts of Dactylis glomerata, Lolium perenne, Secale cereale y Olea europaea by using this method.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2012
Actual (reported)Click on a node to explore related trials.
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February 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 26, 2012
Actual (reported)March 30, 2012
Actual (reported)November 2012
Actual (reported)November 2012
Actual (reported)Wheal size area
The primary efficacy variable will be the wheal size area at the site of the puncture of the immediate phase reaction in mm2.
15 minutes after skin prick test
Patients sensitized to other allergenic sources but the allergen extracts under investigation.
Healthy volunteers.
Skin prick test of 4 concentrations of each allergenic source, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. Assessment of the wheal size after 15 minutes.
Skin prick test of 4 concentrations of each allergenic source,together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. Assessment of the wheal size after 15 minutes.
Hospital de Manises
Manises, Valencia, Spain
Hospital Universitario Infanta Cristina
Badajoz, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Universitario de Guadalajara
Guadalajara, Spain
Complejo Hospitalario de Jaén
Jaén, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Arantza Vega, MD
University of Guadalajara
Pilar Alba, MD
Hospital de Manises
José Manuel Zubeldia, MD
Hospital Universitario Gregorio Marañón
María Ángeles Gonzalo Garijo, MD
Hospital Universitario Infanta Cristina
177 participants (actual enrollment reported by the registry).
First Submitted
March 26, 2012
First Posted
March 30, 2012
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Skin prick test of 4 concentrations of each allergenic source, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every subjects in duplicate on the volar surface of the forearm. Assessment of the wheal size after 15 minutes.
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Contact the study team to confirm eligibility.
Carlos Colás, MD
Hospital Clínico Universitario Lozano Blesa
Blanca Saenz de San Pedro
Complejo Hospitalario de Jaén
Lourdes Fernández, MD
Hospital General Universitario Reina Sofía de Murcia
Primary Completion
November 2012
Actual (reported)Study Completion
November 2012
Actual (reported)Last Updated
May 1, 2017
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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