Biological standardization of allergen extracts of pollen of Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense and Poa pratensis in patients sensitized to them.
- Conditions
- Biological standardization for allergenic extracts in patients with hipersensibility to extracts.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2014-001210-26-ES
- Lead Sponsor
- PROBELTE PHARMA S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 63
- Positive clinical history of allergy inhalation (rhinitis and / or rhinoconjunctivitis and / or asthma) against allergen extract.
- Signed written informed consent.
- Subjects of both sexes, of every race and ethnicity.
- Age between18-60 years old.
- A positive prick test (diameter of the wheal greater or equal than 3 mm) with a standardized allergen extract commercial
- A positive test for specific IgE of the allergen extract in class 3 or higher blood serum
- Patients must live in a geographic area where the allergy caused by the allergen in question is a relevant problem.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 63
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Allergen immunotheraphy in the last 5 years with a Grass pollen extract .
-Drugs that may interfere the cutaneous response 15 days before the study and during the study (eg, antihistamines).
-Patients who had received treatments with: blockers, tetraciclic or tryciclic antidepresives, IMAOS, corticosteroids chronic use of oral corticosteroids, or corticosteroids use orally or parenterally in repeated and intermittent regimens (> 10 mg / day of prednisone or equivalent).
-Pregnant or lactating women
- Dermographism, atopic dermatitis and / or urticaria that affects the skin area where the test is performed.
-Clinically relevant immune system diseases, both autoimmune and immunodeficiency
-Serious uncontrolled illness that may increase the risk to the safety of the subjects participating in this study
-Subjects with diseases or conditions that limit the use of adrenaline (coronary heart disease, severe hypertension, etc..).
-Subjects who have received anti-IgE treatment (Omalizumab).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In vivo determination of biological activity of the extracts of grass pollen, Dactylis glomerata, Festuca pratensis, Lolium perenne, Phleum pratense and Poa pratensis.;Secondary Objective: Determinate the concentration of allergen extract which causes a wheal with equivalent size to that produced by a solution of 10mg/ml Histamine.;Primary end point(s): The wheal size area (mm2) which is produced on the skin after the extract application;Timepoint(s) of evaluation of this end point: 15 minutes after prick test
- Secondary Outcome Measures
Name Time Method Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A