Biological Standardization of Dermatophagoides Pteronyssinus Allergen Extract

NCT01821716 | Completed Phase 2

• 1 other identifier: 101-PR-PRI-196
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Allergy Dermatophagoides Pteronyssinus; Allergic Rhinitis; Allergic Asthma

Keywords

standardization; skin prick test; inmunotherapy

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

Three concentrations of Dermatophagoides pteronyssinus allergen extract (10, 1, 0.1 mg/ml) Positive control (10 mg/ml histamine dihydrochloride) Negative control (glycerinated phenol saline solution)

Biological: Prick test Dermatophagoides pteronyssinus allergen extract

Interventions

Prick test Dermatophagoides pteronyssinus allergen extract BIOLOGICAL

This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines. Three concentrations of Dermatophagoides pteronyssinus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dichloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test.

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Medical history of allergy with respiratory symptoms (rhinitis and /or rhinoconjunctivitis and/or asthma) to Dermatophagoides pteronyssinus.

You may not qualify if:

• Immunotherapy in the past 5 years with a Dermatophagoides pteronyssinus allergen extract or other mites allergen extracts known to interfere with the allergen to be tested, due to a high degree of cross-reactivity.
• Use of drugs that may interfere with the skin reactions (e.g., antihistamines). See Appendix 1 of the protocol.
• Treatment with any of the following medications: oral tricyclic or tetracyclic antidepressants or IMAOs, beta-blockers, chronic use of corticosteroids or use of oral or parenteral corticosteroids in repeated and intermittent patterns (10 mg/daily of prednisone or equivalent).
• Women who are pregnant or period of breastfeeding and women with a pregnancy test positive during the visit 2, prior to the prick test.
• 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.
• Diseases of the immune system relevant clinically, both autoimmune and immunodeficiencies.
• Serious diseases not controlled that may increase the risk for the safety of the subjects involved in this study, including, but not limited to the following: heart failure, uncontrolled or severe respiratory diseases,endocrine diseases, clinically relevant kidney or liver diseases or hematological diseases.
• Patients with diseases or conditions that limit the use of adrenaline (heart disease, severe hypertension...)
• Severe psychiatric, psychological or neurological disorders
• Abuse of alcohol, drugs or medicines in the previous year.

Sponsors & Collaborators

• Laboratorios Leti, S.L.: lead

Study Sites (2)

Hospital de Denia (Marina Salud)

Denia, Alicante, 03700, Spain

Location

Complexo Hospitalario Universitario A Coruña (Hospital Abente y Lago)

A Coruña, 15001, Spain

Location

MeSH Terms

Conditions

Dust Mite Allergy; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, Perennial; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

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: March 27, 2013
• First Posted: April 1, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

ES (2)