Biological Standardization of D. Glomerata, L. Perenne, S. Cereale and O. Europaea Pollen Extracts

NCT01567319 | Completed Phase 1

• 2 other identifiers: BIA-STD-0022011-001270-25
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Sensitization to Allergens

Keywords

Sensitization; Skin Prick Test; Standardization; sources of: D. glomerata, L. perenne, S. cereale and O. europaea

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Allergic Subjects

EXPERIMENTAL

Biological: Skin Prick Test

Atopic Subjects

ACTIVE COMPARATOR

Patients sensitized to other allergenic sources but the allergen extracts under investigation.

Biological: Skin Prick Test - Atopic Subjects

No Atopic Subjects

ACTIVE COMPARATOR

Healthy volunteers.

Biological: Skin Prick Test - No Atopic Subjects

Interventions

Skin Prick Test BIOLOGICAL

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.

Allergic Subjects

Skin Prick Test - Atopic Subjects BIOLOGICAL

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.

Atopic Subjects

Skin Prick Test - No Atopic Subjects BIOLOGICAL

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.

No Atopic Subjects

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A. Subjects sensitized to one or more allergen extracts:
• Positive clinical history with inhalant allergy to at least one of the allergen to be standardized.
• At least one positive prick test (mean wheal diameter greater or equal than 3mm) .
• Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml
• Age: 18-60 years
• Written informed consent
• Patients will preferably be monosensitized, or with clinically relevant sensitization , or with primary sensitization (maximum cutaneous reactivity) to the extracts under investigation.
• Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
• B. Atopic Subjects:
• Age: 18-60 years
• Written informed consent
• Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml
• Negative prick test (mean wheal diameter less or equal to 3mm) when tested with already standardized extracts of the allergens under investigation or with cross reactive extracts.
• Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.
• C. No Atopic Subjects:

You may not qualify if:

• Immunotherapy in the 2 years prior to the study against either the allergen to be tested or an allergen which is cross-reactive. (it is not applicable to no atopic patients)
• Any drug which may interfere with the cutaneous test or with its result.
• Any medical condition that from investigator's point of view the skin prick test cannot be done .
• Women who are pregnant or breast-feeding or are child-bearing age and who have not demonstrated that they have been surgically sterilized or have other means of not bearing children.
• Subjects who have participated in another clinical trial within 3 months prior to this study.

Sponsors & Collaborators

• Roxall Medicina España S.A: lead

Study Sites (7)

Hospital de Manises

Manises, Valencia, Spain

Location

Hospital Universitario Infanta Cristina

Badajoz, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Universitario de Guadalajara

Guadalajara, Spain

Location

Complejo Hospitalario de Jaén

Jaén, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Location

MeSH Terms

Interventions

Patch Tests

Intervention Hierarchy (Ancestors)

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

Study Officials

• Arantza Vega, MD

  Hospital Universitario de Guadalajara

  PRINCIPAL INVESTIGATOR

• Pilar Alba, MD

  Hospital de Manises

  PRINCIPAL INVESTIGATOR

• José Manuel Zubeldia, MD

  Hospital Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

• María Ángeles Gonzalo Garijo, MD

  Hospital Universitario Infanta Cristina

  PRINCIPAL INVESTIGATOR

• Carlos Colás, MD

  Hospital Clínico Universitario Lozano Blesa

  PRINCIPAL INVESTIGATOR

• Blanca Saenz de San Pedro

  Complejo Hospitalario de Jaén

  PRINCIPAL INVESTIGATOR

• Lourdes Fernández, MD

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 30, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

ES (7)