Allergy to Chenopodium Album Clinical Trial
Official title:
Biological Standardization of Chenopodium Album Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units
The objective of this study is to determine the biologic activity of a Chenopodium album allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable). - Subject can be male or female of any race and ethnic group. - Age > and =18 years and < and =60 years at the study inclusion day. - Positive skin prick test with a standardized commercially available preparation of chenopodium album allergen extract. - A positive test for specific IgE to chenopodium album (CAP-RAST major or equal to 2). - Allergic symptoms during the pollen season of Chenopodium album. - Medical history positive allergy inhalation (rhinitis and /or rhinoconjunctivitis and/or asthma) from Chenopodium album. Exclusion Criteria: - Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested. - Use of drugs that may interfere with the skin reactions (e.g., antihistamines). - Treatment with any of the following medications: tricyclic or tetracyclic o IMAOs antidepressants,b-blockers or chronic use of corticosteroids or oral or use of corticoids both via oral or parenteral, in repeated patterns and intermittent (> 10 mg/día de prednisone or equivalent). - Women who are pregnant or period of breastfeeding and women with a pregnancy test positive during the visit 2, prior to the prick test. - Dermographism affecting the skin area at the test site at either study visit. - Atopic dermatitis affecting the skin area at the test site at either study visit. - Urticaria affecting the skin area at the test site at either study visit. - Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies. - Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases, endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases. - Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial. - Patients with diseases or conditions that limit the use of adrenaline (heart disease, severe hypertension, ..) - Severe psychiatric, psychological or neurological disorders - Abuse of alcohol, drugs or medicines in the previous year. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital General de Elche | Alicante | |
| Spain | Centro Médico Adeslas | Córdoba |
| Lead Sponsor | Collaborator |
|---|---|
| Laboratorios Leti, S.L. |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. | 15-20 min after application | No |