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Trial record 37 of 1210 for:    HISTAMINE

Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)

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ClinicalTrials.gov Identifier: NCT02512653
Recruitment Status : Completed
First Posted : July 31, 2015
Last Update Posted : June 20, 2016
Sponsor:
Information provided by (Responsible Party):
Laboratorios Leti, S.L.

Brief Summary:
Biological Standardization of Cupressus arizonica Allergen Extract.

Condition or disease Intervention/treatment Phase
Allergy to Tree Pollen Biological: Cupressus arizonica Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)
Study Start Date : November 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Cupressus arizonica allergen extract at 4 different concentrations. Positive control. Negative control
Biological: Cupressus arizonica
Four different concentrations of Cupressus arizonica allergen extract, positive control and negative control




Primary Outcome Measures :
  1. Wheal size area (mm2) on the skin at the site of the puncture during the inmediate phase [ Time Frame: Test sites should be inspected and recorded 15-20 min after application ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has provided written informed consent, appropriately signed and dated by subject.
  • Subject can be male or female of any race and ethinic group.
  • Age 18 years and 60 years ata the study inclusión day.
  • Positive clinical history of inhalatory allergy to Cupressus arizonica.
  • A positive prick test with a standarices commercially Cupressus arizonica allergen extract.
  • A positive prick test with positive control of histamine 10 mg/ml.
  • A positive test for specific IgE to Cupressus arizonica.

Exclusion Criteria:

  • Immunotherapy in the past 5 years with an allergen extract Cupressus arizonca or other allergen extract than may interfere with the allergene to be tested.
  • Use of drugs that may interfere before and after with the skin reactions.
  • Treatment with certain drugs.

Information from the National Library of Medicine

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): NCT02512653


Locations
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Spain
Hospital Universitario de Fuenlabrada
Fuenalabrada, Madrid, Spain, 28942
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Sponsors and Collaborators
Laboratorios Leti, S.L.
Investigators
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Study Chair: Lena Erbiti Laboratorios Leti, S.L.U

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Responsible Party: Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier: NCT02512653     History of Changes
Other Study ID Numbers: 608-PR-PRI-199
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Keywords provided by Laboratorios Leti, S.L.:
Allergy to Cupressus pollen
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs