Biological Standardization of Poa Pratensis Allergen Extract
|Allergy to Grass Pollen||Biological: Four different concentrations of Poa pratensis allergen extract, positive control and negative control||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Biological Standardization of Poa Pratensis Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units|
- Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. [ Time Frame: Test sites should be inspected and recorded 15-20 min after application ]
|Study Start Date:||October 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Poa pratensis allergen extract at 4 different concentrations.
Biological: Four different concentrations of Poa pratensis allergen extract, positive control and negative control
Four concentrations of Poa pratensis allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
Four concentrations of Poa pratensis allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430117
|C.E. Virgen de la Cinta - Hospital Juan Ramón Jiménez|
|Huelva, Andalucía, Spain, 21003|
|Hospital Universitario Marqués de Valdecilla|
|Santander, Cantabria, Spain, 39008|
|Study Chair:||María José Gómez||Laboratorios LETI, S.L.Unipersonal|