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

NCT01984541 | Completed Phase 2

• 2 other identifiers: 6058-PR-PRI-2002013-001310-15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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).

Conditions

Allergy to Pollen

Keywords

Pollen

Outcome Measures

Primary Outcomes (1)

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

  15-20 min after aplication

Study Arms (1)

1

EXPERIMENTAL

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

Biological: Artemisia vulgaris

Interventions

Artemisia vulgaris BIOLOGICAL

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.

Also known as: Four different concentrations of Artemisia vulgaris allergen extract, positive control and negative control

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Laboratorios Leti, S.L.: lead

Study Sites (2)

Hospital de La Agencia Valenciana de Salud Vega Baja

Orihuela, Alicante, 03314, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Lena Erbiti

  Laboratorios Leti, S.L.U

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 14, 2013
• Study Start: March 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 5, 2015

Record last verified: 2013-05

Locations

ES (2)