Biological Standardization of Dactylis Glomerata Allergen Extract
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|ClinicalTrials.gov Identifier: NCT01407835|
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : August 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Allergy to Grass Pollen (Dactylis Glomerata)||Biological: Four different concentrations of Dactylis glomerata allergen extract, positive control and negative control||Phase 2|
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 Dactylis glomerata 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biological Standardization of Dactylis Glomerata Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||June 2012|
Biological: Four different concentrations of Dactylis glomerata allergen extract, positive control and negative control
Four concentrations of Dactylis glomerata allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407835
|Hospital Universitario La Princesa|
|Madrid, Madrid / Madrid, Spain, 28005|
|Hospital El Tomillar - Area Hospitalaria de Valme|
|Sevilla, Sevilla / Andalucía, Spain, 41700|
|Study Chair:||María José Gómez||Laboratorios LETI, S.L.Unipersonal|