Biological standardization for allergenic extracts in patients with hipersensibility to extracts.
Conditions
Interventions
Product Name: Extracto alergénico de polen de Dactylis glomerata
Pharmaceutical Form: Solution for skin-prick test
INN or Proposed INN: DACTYLIS GLOMERATA POLLEN EXTRAC
Sponsors
PROBELTE PHARMA S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: -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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Spain
Contacts
Public ContactMedical Deparment
PROBELTE PHARMA S.A.
Outcome results
None listed