Status:
COMPLETED
Biological Standardization of Secale Cereale Allergen Extract
Lead Sponsor:
Laboratorios Leti, S.L.
Conditions:
Allergy to Grass Pollen (Secale Cereale)
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The objective of this study is to determine the biologic activity of a Secale cereale allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation ...
Detailed Description
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 Secale cerea...
Eligibility Criteria
Inclusion
- 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 \< 50 years at the study inclusion day.
- Positive skin prick test with a standardized commercially available preparation of Secale cereale allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study
- A positive test for specific IgE to Secale cereale (CAP-RAST ≥ 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.
- Allergic symptoms during the pollen season of Secale cereale.
- Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm.
Exclusion
- 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, β-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.
- Subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension, ..)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01408238
Start Date
October 1 2011
End Date
June 1 2012
Last Update
August 9 2012
Active Locations (2)
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1
Hospital Universitario La Paz
Madrid, Madrid / Madrid, Spain, 28046
2
Hospital Universitario Virgen Macarena
Seville, Sevilla / Andalucía, Spain, 41009