Biological Standardization of Blomia Tropicalis Allergen Extract

NCT01597752 | Completed Phase 2

• 2 other identifiers: 107-PR-PRI-1852011-003634-14
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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).

Conditions

Allergy to Mites

Keywords

Immunotherapy; Skin prick test; Standardization; Blomia tropicalis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

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

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

Interventions

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

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A documented positive case history with inhalation allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) related to Blomia tropicalis.
• 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.
• Allergic symptoms during the season of Blomia tropicalis.
• Mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm.

You may not qualify if:

• Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., mites group extracts).
• Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1
• Treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (\> 10 mg/day of prednisone or equivalent).
• Pregnancy.
• 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.
• Participation in another clinical trial within the last month.
• Subjects suffering from pathologies or conditions in which adrenalin is contraindicated (heart disease, severe hypertension,...)

Sponsors & Collaborators

• Laboratorios Leti, S.L.: lead

Study Sites (2)

Hospital Universitario de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, Canary Islands, 35012, Spain

Location

Complejo Hospitalario Universitario Insular Materno-Insular

Las Palmas de Gran Canarias, Canary Islands, 35016, Spain

Location

Study Officials

• María José Gómez

  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: May 10, 2012
• First Posted: May 14, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 30, 2012

Record last verified: 2012-05

Locations

ES (2)