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Biological Standardization of Lolium Perenne Allergen Extract

NCT01394289 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2012-08-27

No results posted yet for this study

Summary

The objective of this study is to determine the biologic activity of a Lolium perenne allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

Conditions

  • Allergy to Grass Pollen

Interventions

BIOLOGICAL

Lolium allergen extract

This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines. Four concentrations of Lolium perenne 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. This test will be referred to as the Titrated Skin Prick test.

Sponsors & Collaborators

  • Laboratorios Leti, S.L.

    lead INDUSTRY

Principal Investigators

  • María José Gómez · Laboratorios LETI, S.L.U

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01394289 on ClinicalTrials.gov