Sensitization to Allergens Clinical Trial
Official title:
Biological Standardization of D. Glomerata, L. Perenne, S. Cereale and O. Europaea Pollen Extracts in Patients Sensitized to Them.
| Verified date | April 2017 |
| Source | Roxall Medicina España S.A |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 177 |
| Est. completion date | November 2012 |
| Est. primary completion date | November 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| 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 de Manises | Manises | Valencia |
| Spain | Hospital Clínico Universitario Lozano Blesa | Zaragoza |
| Lead Sponsor | Collaborator |
|---|---|
| Roxall Medicina España S.A |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |