Allergy to Poa pratensis. MedDRA version: 14.0 Level: LLT Classification code 10036019 Term: Pollen allergy System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: Extracto alergénico de Poa Pratensis
Product Code: 183
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Extracto alergénico de Poa pratensis
Concentration unit: mg/ml milligr
Sponsors
Laboratorios Leti, S.L.Unipersonal
Eligibility
Sex/Gender
All
Inclusion criteria
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 > 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 (e.g., grass group extracts). -Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1 -Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, ?-blockers or corticosteroids (> 10 mg/day of prednisone or equivalent). -Pregnancy. -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. -Participation in another clinical trial within the last month. -Patients with diseases or conditions that limit the use of adrenaline (heart disease, severe hypertension, ..)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the concentration of Lolium perenne allergen extract that elicits a wheal size equivalent to that of a 10 mg/ml histamine dyhidrochloride solution.;Secondary Objective: In this study there are no secondary objectives.;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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No secondary endpoints in this study;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Spain
Contacts
Public ContactÁrea de Investigación Clínica
Laboratorios LETI, S.L.U
Outcome results
None listed