Biological Standardization of Poa Pratensis Allergen Extract

Allergy to Grass Pollen Clinical Trial

Official title:

Biological Standardization of Poa Pratensis Allergen Extract to Determine the Biological Activity in Histamine Equivalent Prick (HEP) Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430117
• Other study ID #: 6045-PR-PRI-183
• Secondary ID: 2010-023950-35
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2011
• Last updated: August 20, 2012
• Start date: October 2011
• Est. completion date: February 2012

Study information

• Verified date: August 2012
• Source: Laboratorios Leti, S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

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

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 Poa pratensis 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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

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 Poa pratensis 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 Poa pratensis(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 pollen season of Poa pratensis.

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., grass 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, ß-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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Allergy to Grass Pollen
• Hypersensitivity

Intervention

Biological:
• Four different concentrations of Poa pratensis allergen extract, positive control and negative control
Four concentrations of Poa pratensis allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.

Locations

Country	Name	City	State
Spain	C.E. Virgen de la Cinta - Hospital Juan Ramón Jiménez	Huelva	Andalucía
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Leti, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No