Biological Standardization of Blomia Tropicalis Allergen Extract

NCT ID: NCT01597752

Last Updated: 2012-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-09-30

Brief Summary

The objective of this study is to determine the biologic activity of a Blomia tropicalis allergen extract in histamine equivalent prick (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. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.

Four concentrations of Blomia tropicalis 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.

Conditions

Allergy to Mites

Keywords

Immunotherapy; Skin prick test; Standardization; Blomia tropicalis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Blomia tropicalis allergen extract (four concentrations: 5, 0.5, 0.05, 0.005 mg/ml)

Positive control

Negative control

Group Type: EXPERIMENTAL

Four different concentrations of Blomia tropicalis allergen extract, positive control and negative control

Intervention Type: BIOLOGICAL

Four concentrations of Blomia tropicalis allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.

Interventions

Four different concentrations of Blomia tropicalis allergen extract, positive control and negative control

Four concentrations of Blomia tropicalis allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. A documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to Blomia tropicalis.

2. Subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable).

3. Subject can be male or female of any race and ethnic group.

4. Age > 18 years and < 50 years at the study inclusion day.

5. Positive skin prick test with a standardized commercially available preparation of Blomia tropicalis allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study

6. A positive test for specific IgE to Blomia tropicalis(CAP-RAST ≥ 2). IgE results are valid if performed within one year prior to the inclusion of the subject in the study.

7. Allergic symptoms during the season of Blomia tropicalis.

8. Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm.

Exclusion Criteria

1. Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., mites group extracts).

2. Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1

3. Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (> 10 mg/day of prednisone or equivalent).

4. Pregnancy.

5. Dermographism affecting the skin area at the test site at either study visit.

6. Atopic dermatitis affecting the skin area at the test site at either study visit.

7. Urticaria affecting the skin area at the test site at either study visit.

8. Participation in another clinical trial within the last month.

9. Subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension,...)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratorios Leti, S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

María José Gómez

Role: STUDY_CHAIR

Laboratorios LETI, S.L.Unipersonal

Locations

Hospital Universitario de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, Canary Islands, Spain

Complejo Hospitalario Universitario Insular Materno-Insular

Las Palmas de Gran Canarias, Canary Islands, Spain

Countries

Spain

Other Identifiers

2011-003634-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

107-PR-PRI-185

Identifier Type: -

Identifier Source: org_study_id