Biological Standardization of Blomia Tropicalis Allergen Extract

Phase 2

Completed

• Conditions: Allergy to Mites
• Interventions: Biological: Four different concentrations of Blomia tropicalis allergen extract, positive control and negative control

• Registration Number: NCT01597752
• Lead Sponsor: Laboratorios Leti, S.L.

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.

Study Timeline

• Study Start: 2012-04
• Status Verified: 2012-05
• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-10
• Study First Posted: 2012-05-14
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-11-29
• Last Update Posted: 2012-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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,...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Four different concentrations of Blomia tropicalis allergen extract, positive control and negative control	Blomia tropicalis allergen extract (four concentrations: 5, 0.5, 0.05, 0.005 mg/ml) Positive control Negative control

Primary Outcome Measures

Name	Time	Method
Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.	Test sites should be inspected and recorded 15-20 min after application

Trial Locations

Locations (2)

Hospital Universitario de Gran Canaria Dr. Negrín; 🇪🇸 Las Palmas de Gran Canaria, Canarias, Spain

Complejo Hospitalario Universitario Insular Materno-Insular; 🇪🇸 Las Palmas de Gran Canarias, Canarias, Spain