Back to resultsBiological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)
Primary Purpose
Allergy to Tree Pollen
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Cupressus arizonica
Sponsored by
About this trial
This is an interventional diagnostic trial for Allergy to Tree Pollen focused on measuring Allergy to Cupressus pollen
Eligibility 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.
Sites / Locations
- Hospital Universitario de Fuenlabrada
- Hospital Universitario Puerta de Hierro
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Cupressus arizonica allergen extract at 4 different concentrations. Positive control. Negative control
Outcomes
Primary Outcome Measures
Wheal size area (mm2) on the skin at the site of the puncture during the inmediate phase
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02512653
Brief Title
Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)
Official Title
Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Leti, S.L.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Biological Standardization of Cupressus arizonica Allergen Extract.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy to Tree Pollen
Keywords
Allergy to Cupressus pollen
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cupressus arizonica allergen extract at 4 different concentrations. Positive control. Negative control
Intervention Type
Biological
Intervention Name(s)
Cupressus arizonica
Intervention Description
Four different concentrations of Cupressus arizonica allergen extract, positive control and negative control
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena Erbiti
Organizational Affiliation
Laboratorios Leti, S.L.U
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenalabrada
State/Province
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Biological Standarization of Cupressus Arizonica Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP)
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