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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Laboratorios Leti, S.L.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:
NCT01984541
First received: November 8, 2013
Last updated: March 27, 2014
Last verified: May 2013
  Purpose

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).


Condition Intervention Phase
Allergy to Pollen
Biological: Artemisia vulgaris
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Biological Standardization of Artemisia Vulgaris Allergen Extract to Determine the Biological Activity in Histamine Equivalent Units (HEP).

Resource links provided by NLM:


Further study details as provided by Laboratorios Leti, S.L.:

Primary Outcome Measures:
  • Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. [ Time Frame: 15-20 min after aplication ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2014
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Artemisia vulgaris allergen extract(four concentrations 10, 1, 0,1 y 0,01 mg/ml) Positive Control Negative Control
Biological: Artemisia vulgaris
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.
Other Name: Four different concentrations of Artemisia vulgaris allergen extract, positive control and negative control

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984541

Contacts
Contact: Lena Erbiti 34 91 771 1790 lerbiti@leti.com
Contact: David Sanchez 34 91 771 1790 dramos@leti.com

Locations
Spain
Hospital de La Agencia Valenciana de Salud Vega Baja Recruiting
Orihuela, Alicante, Spain, 03314
Contact: Mª Isabel Peña, MD         
Principal Investigator: Mª Isabel Peña, MD         
Hospital Clinic de Barcelona Not yet recruiting
Barcelona, Spain, 08036
Contact: Antonio Valero, MD    34 93 227 5540    valero@clinic.ub.es   
Principal Investigator: Antonio Valero, MD         
Sponsors and Collaborators
Laboratorios Leti, S.L.
Investigators
Study Chair: Lena Erbiti Laboratorios Leti, S.L.U
  More Information

No publications provided

Responsible Party: Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier: NCT01984541     History of Changes
Other Study ID Numbers: 6058-PR-PRI-200, 2013-001310-15
Study First Received: November 8, 2013
Last Updated: March 27, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Laboratorios Leti, S.L.:
Pollen

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014