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To Determine the Minimum Amount of Artemisia Vulgaris Allergen Extract Producing a Positive Skin Reaction.

Primary Purpose

Allergy to Pollen

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Artemisia vulgaris
Sponsored by
Laboratorios Leti, S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Allergy to Pollen focused on measuring Pollen

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Positive clinical history of inhalatory allergy to Artemisia vulgaris. Subject has provided written informed consent, appropriately signed and dated by the subject.

Subject can be male or female of any race and ethinic group. Age major or equal 18 years and ninor or equal 60 years at the study inclusion day.

A positive prick test with a standardized commercially Artemisia vulgaris allergen extract (Wheal medium diameter ≤ 3mm or wheal area ≥ 7 mm2). The 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 Artemisia vulgaris (CAP-RAST major or equal to 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.

Allergy symptoms during the Artemisia vulgaris pollen season.

Exclusion Criteria:

Immunotherapy in the past 5 years with an allergen extract Artemisia vulgaris or other allergen extract that may interfere with the allergene to be tested (for example: Helianthus annuus (sunflower) elatior Ambrosia eiator (ambrosia) or peach.

Use of drugs that may interfere before and after with the skin reactions (for example: antihistamines).

Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants, beta-blockers, corticosteroids (major 10 mg/daily of prednisone or equivalent).

Women who are pregnant or breastfeeding period and women with positive pregnancy test at Visit 2, before skin prick test.

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. Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies.

Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases, endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases. Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial.

Patients with diseases or conditions that limit the use of adrenaline. Severe psychiatric, psychological or neurological disorders. Abuse of alcohol, drugs or medicines in the previous year. Subjects who have received anti-IgE (Omalizumab).

Sites / Locations

  • Hospital de La Agencia Valenciana de Salud Vega Baja
  • Hospital Clinic de Barcelona

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Artemisia vulgaris allergen extract(four concentrations 10, 1, 0,1 y 0,01 mg/ml) Positive Control Negative Control

Outcomes

Primary Outcome Measures

Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.

Secondary Outcome Measures

Full Information

First Posted
November 8, 2013
Last Updated
January 2, 2015
Sponsor
Laboratorios Leti, S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT01984541
Brief Title
To Determine the Minimum Amount of Artemisia Vulgaris Allergen Extract Producing a Positive Skin Reaction.
Official Title
Biological Standardization of Artemisia Vulgaris Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (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
The objective of this study is to determine the biological activity of Artemisia vulgaris allergen extract in histamine equivalent units (HEP) units, in order to be used as in-house reference preparation (IHRP).
Detailed Description
This is an open, unblinded and non-randomized biological assay. Tehe study design is a slight modification of the recommendations proposed by the Nordic Guidelines. Four concentrations of Artemisia vulgaris 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy to Pollen
Keywords
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
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Artemisia vulgaris allergen extract(four concentrations 10, 1, 0,1 y 0,01 mg/ml) Positive Control Negative Control
Intervention Type
Biological
Intervention Name(s)
Artemisia vulgaris
Other Intervention Name(s)
Four different concentrations of Artemisia vulgaris allergen extract, positive control and negative control
Intervention Description
Four concentrations of Artemisia vulgaris allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
Primary Outcome Measure Information:
Title
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.
Time Frame
15-20 min after aplication

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: Positive clinical history of inhalatory allergy to Artemisia vulgaris. Subject has provided written informed consent, appropriately signed and dated by the subject. Subject can be male or female of any race and ethinic group. Age major or equal 18 years and ninor or equal 60 years at the study inclusion day. A positive prick test with a standardized commercially Artemisia vulgaris allergen extract (Wheal medium diameter ≤ 3mm or wheal area ≥ 7 mm2). The 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 Artemisia vulgaris (CAP-RAST major or equal to 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study. Allergy symptoms during the Artemisia vulgaris pollen season. Exclusion Criteria: Immunotherapy in the past 5 years with an allergen extract Artemisia vulgaris or other allergen extract that may interfere with the allergene to be tested (for example: Helianthus annuus (sunflower) elatior Ambrosia eiator (ambrosia) or peach. Use of drugs that may interfere before and after with the skin reactions (for example: antihistamines). Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants, beta-blockers, corticosteroids (major 10 mg/daily of prednisone or equivalent). Women who are pregnant or breastfeeding period and women with positive pregnancy test at Visit 2, before skin prick test. 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. Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies. Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases, endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases. Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial. Patients with diseases or conditions that limit the use of adrenaline. Severe psychiatric, psychological or neurological disorders. Abuse of alcohol, drugs or medicines in the previous year. Subjects who have received anti-IgE (Omalizumab).
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 de La Agencia Valenciana de Salud Vega Baja
City
Orihuela
State/Province
Alicante
ZIP/Postal Code
03314
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

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To Determine the Minimum Amount of Artemisia Vulgaris Allergen Extract Producing a Positive Skin Reaction.

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