Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917488
• Other study ID #: 108-PR-PRI-147
• Secondary ID: 2007-000904-33
• Status: Completed
• Phase: Phase 2
• First received: June 8, 2009
• Last updated: June 17, 2011
• Start date: May 2009
• Est. completion date: July 2010

Study information

• Verified date: June 2011
• 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 main purpose of the trial is to prove the therapeutic value of the product and enable an effective and safe dosage schedule to be recommended

Description:

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

The skin testing procedure, based on the Nordic Guidelines is the reference method for the biological calibration of in-House Reference Preparations (IHRP). The method is not intended for routine testing of allergen extracts. The use of this procedure is the basis for the definition of biological activity units: "the activity of an allergen extract is 10,000 Biological Units (BU) per ml (10 HEP per ml), when the extract provokes an specific skin reaction in the median sensitive patient with a wheal of the same size as a wheal provoked by a positive reference solution consisting of histamine 54.3 mmol/l (for example histamine dihydrochloride 10 mg/ml), when both solutions are administrated using the same technique (prick testing) on at least 20 individuals who are clinically allergic and cutaneously reactive to the allergen concerned".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Subject inclusion criteria:

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

2. Positive skin prick test with an available preparation of the same allergen extract (a wheal major diameter of at least 3 mm) and/or a positive test for specific IgE.

3. Mean of the areas of the wheals provoked by histamine dihydrochloride (10 mg/ml) = 7 mm2.

4. Age = 18 years and = 50 years

5. Subject can be male or female

6. Subject must be capable of providing written informed consent

Subject exclusion criteria:

1. Subjects should not be excluded due to low or high sensitivity to Glycyphagus domesticus.

2. Immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested.

3. Use of drugs that may interfere with the skin reactions.

4. Pregnancy, dermographism, atopic dermatitis (locally at the test site), urticaria.

5. Any disease which prohibits the use of adrenaline (hyperthyroidism, arterial hypertension, cardiopathy, etc.)

6. Lack of cooperation which may interfere with the study, or subjects with severe psychiatric, psychological or neurological disorders.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Other:
• Standardization of allergenic extract (Gly. domesticus)
Allergenic extract for cutaneous prick-test

Locations

Country	Name	City	State
Spain	Clinica Dr. Lobatón	Cádiz	Cadiz

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.		45 minutes per subject	No