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

Allergy to Tree Pollen Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512653
• Other study ID #: 608-PR-PRI-199
• Status: Completed
• Phase: Phase 2
• First received: July 29, 2015
• Last updated: June 17, 2016
• Start date: November 2015
• Est. completion date: January 2016

Study information

• Verified date: June 2016
• Source: Laboratorios Leti, S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

Biological Standardization of Cupressus arizonica Allergen Extract.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Allergy to Tree Pollen
• Hypersensitivity

Intervention

Biological:
• Cupressus arizonica
Four different concentrations of Cupressus arizonica allergen extract, positive control and negative control

Locations

Country	Name	City	State
Spain	Hospital Universitario de Fuenlabrada	Fuenalabrada	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Leti, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wheal size area (mm2) on the skin at the site of the puncture during the inmediate phase		Test sites should be inspected and recorded 15-20 min after application	No