Biological Standardization of Dactylis Glomerata Allergen Extract

NCT01407835 | Completed Phase 2

• 2 other identifiers: 6038-PR-PRI-1812010-023948-33
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Allergy to Grass Pollen (Dactylis Glomerata)

Keywords

Immunotherapy; Skin prick test; Standardization; Dactylis glomerata

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

* Dactylis glomerata allergen extract at 4 different concentrations * Positive control * Negative control

Biological: Four different concentrations of Dactylis glomerata allergen extract, positive control and negative control

Interventions

Four different concentrations of Dactylis glomerata allergen extract, positive control and negative control BIOLOGICAL

Four concentrations of Dactylis glomerata 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 Dactylis glomerata.
• 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 pollen season of Dactylis glomerata.
• 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., grass 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 La Princesa

Madrid, Madrid / Madrid, 28005, Spain

Location

Hospital El Tomillar - Area Hospitalaria de Valme

Seville, Sevilla / Andalucía, 41700, Spain

Location

Study Officials

• María José Gómez

  Laboratorios LETI, S.L.Unipersonal

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 2, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 9, 2012

Record last verified: 2012-08

Locations

ES (2)