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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BIAL Industrial Farmacéutica S.A.
ClinicalTrials.gov Identifier:
NCT01567319
First received: March 26, 2012
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Sensitization to Allergens
Biological: Skin Prick Test
Biological: Skin Prick Test - Atopic Subjects
Biological: Skin Prick Test - No Atopic Subjects
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Biological Standardization of D. Glomerata, L. Perenne, S. Cereale and O. Europaea Pollen Extracts in Patients Sensitized to Them.

Further study details as provided by BIAL Industrial Farmacéutica S.A.:

Primary Outcome Measures:
  • Wheal size area [ Time Frame: 15 minutes after skin prick test ] [ Designated as safety issue: No ]
    The primary efficacy variable will be the wheal size area at the site of the puncture of the immediate phase reaction in mm2.


Enrollment: 177
Study Start Date: February 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allergic Subjects Biological: Skin Prick Test
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.
Active Comparator: Atopic Subjects
Patients sensitized to other allergenic sources but the allergen extracts under investigation.
Biological: Skin Prick Test - Atopic Subjects
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.
Active Comparator: No Atopic Subjects
Healthy volunteers.
Biological: Skin Prick Test - No Atopic Subjects
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

A. Subjects sensitized to one or more allergen extracts:

  1. Positive clinical history with inhalant allergy to at least one of the allergen to be standardized.
  2. At least one positive prick test (mean wheal diameter greater or equal than 3mm) .
  3. Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml
  4. Age: 18-60 years
  5. Written informed consent
  6. Patients will preferably be monosensitized, or with clinically relevant sensitization , or with primary sensitization (maximum cutaneous reactivity) to the extracts under investigation.
  7. Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.

B. Atopic Subjects:

  1. Age: 18-60 years
  2. Written informed consent
  3. Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml
  4. 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.
  5. Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.

C. No Atopic Subjects:

  1. Age: 18-60 years.
  2. Written informed consent
  3. Positive prick test (wheal diameter greater or equal to 3 mm) to Histamine 10 mg/ml
  4. Negative prick test (mean wheal diameter less or equal to 3mm)to all allergens tested in diagnostic prick test.
  5. Women of child-bearing potential must have a negative urine pregnancy test at the time they begin the study.

Exclusion Criteria (shared by the 3 groups):

  1. 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)
  2. Any drug which may interfere with the cutaneous test or with its result.
  3. Any medical condition that from investigator's point of view the skin prick test cannot be done .
  4. 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.

4.Subjects who have participated in another clinical trial within 3 months prior to this study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01567319

Locations
Spain
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
Sponsors and Collaborators
BIAL Industrial Farmacéutica S.A.
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: BIAL Industrial Farmacéutica S.A.
ClinicalTrials.gov Identifier: NCT01567319     History of Changes
Other Study ID Numbers: BIA-STD-002, 2011-001270-25
Study First Received: March 26, 2012
Last Updated: February 14, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by BIAL Industrial Farmacéutica S.A.:
Sensitization
Skin Prick Test
Standardization
sources of: D. glomerata, L. perenne, S. cereale and O. europaea

ClinicalTrials.gov processed this record on September 18, 2014