Biological Standardization of Chenopodium Album Allergen Extract

NCT01675349 | Completed Phase 2

• 1 other identifier: 6062 -PR-PRI-195
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to determine the biologic activity of a Chenopodium album allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

Conditions

Allergy to Chenopodium Album

Keywords

Standardization; Immunotherapy; Skin prick test

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 application

Study Arms (1)

Chenopodium album allergen extract

EXPERIMENTAL

Four concentrations of Chenopodium album 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. This test will be referred to as the Titrated Skin Prick test.

Biological: Prick test Chenopodium album allergen extract

Interventions

Prick test Chenopodium album allergen extract BIOLOGICAL

This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines. Four concentrations of Chenopodium album 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. This test will be referred to as the Titrated Skin Prick test.

Also known as: Chenopodium album allergen extract,

Chenopodium album allergen extract

Eligibility Criteria

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

You may qualify if:

• Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).
• Subject can be male or female of any race and ethnic group.
• Positive skin prick test with a standardized commercially available preparation of chenopodium album allergen extract.
• A positive test for specific IgE to chenopodium album (CAP-RAST major or equal to 2).
• Allergic symptoms during the pollen season of Chenopodium album.
• Medical history positive allergy inhalation (rhinitis and /or rhinoconjunctivitis and/or asthma) from Chenopodium album.

You may not qualify if:

• Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested.
• Use of drugs that may interfere with the skin reactions (e.g., antihistamines).
• Treatment with any of the following medications: tricyclic or tetracyclic
• o IMAOs antidepressants,b-blockers or chronic use of corticosteroids or oral or use of corticoids both via oral or parenteral, in repeated patterns and intermittent (\> 10 mg/día de prednisone or equivalent).
• Women who are pregnant or period of breastfeeding and women with a pregnancy test positive during the visit 2, prior to the 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.
• Patients with diseases or conditions that limit the use of adrenaline (heart disease, severe hypertension, ..)
• Severe psychiatric, psychological or neurological disorders
• Abuse of alcohol, drugs or medicines in the previous year.

Sponsors & Collaborators

• Laboratorios Leti, S.L.: lead

Study Sites (2)

Hospital General de Elche

Alicante, Alicante, Spain

Location

Centro Médico Adeslas

Córdoba, Córdoba, 14006, Spain

Location

Study Officials

• Lena Erbiti

  Laboratorios LETI, S.L.Unipersonal

  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: August 27, 2012
• First Posted: August 29, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 23, 2014

Record last verified: 2012-08

Locations

ES (2)