Allergy to Alternaria alternata
Conditions
Interventions
Trade Name: PRICK TEST Alternaria alternata LETI
Product Name: Extracto alergénico nativo de Alternaria alternata
Pharmaceutical Form: Solution for skin-prick test
INN or Proposed INN: Extracto alerge
Sponsors
LABORATORIOS LETI S.L.U
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Positive clinical history of inhalatory allergy to Alternaria alternata with (meaning: rhinitis and / or rhinoconjunctivitis and / or asthma) -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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (for example: fungal extracts) -Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1 of the protocol. -Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants, beta-blockers, corticosteroids (major 10 mg/daily of prednisone or equivalent). - Women who are pregnant or breastfeeding period and women with positive pregnancy test at Visit 1 or 2 -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. -Subjects who have received anti-IgE (Omalizumab).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective is to perform the in vitro characterization of the internal reference preparation from Subject's serum, to determine their in vitro biological potency and to guarantee the consistency of the biological potency of the product batch by batch.;Primary end point(s): Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.;Timepoint(s) of evaluation of this end point: The primary endpoint will be determined after the last patient last visit(end of study).;Main Objective: The primary objective is to assess the concentration of alternaria alternata allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The potency of in vitro PRI.;Timepoint(s) of evaluation of this end point: The secundary endpoint will be determined after the last patient last visit (end of study). | — |
Countries
Spain
Contacts
Public ContactDepartamento Médico
LABORATORIOS LETI S.L.U
Outcome results
None listed