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

NCT00917488 | Completed Phase 2

• 2 other identifiers: 108-PR-PRI-1472007-000904-33
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic

Keywords

Allergen extract Standardization

Outcome Measures

Primary Outcomes (1)

• Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase.

  45 minutes per subject

Study Arms (1)

A

EXPERIMENTAL

Four concentrations of Glycyphagus domesticus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, was tested in every patient in duplicate on the volar surface of the forearm.

Other: Standardization of allergenic extract (Gly. domesticus)

Interventions

Standardization of allergenic extract (Gly. domesticus) OTHER

Allergenic extract for cutaneous prick-test

A

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 Glycyphagus domesticus.
• 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.
• Mean of the areas of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 7 mm2.
• Age ≥ 18 years and ≤ 50 years
• Subject can be male or female
• Subject must be capable of providing written informed consent

You may not qualify if:

• Subjects should not be excluded due to low or high sensitivity to Glycyphagus domesticus.
• Immunotherapy in the past 2 years with an allergen preparation known to interfere with the allergens to be tested.
• Use of drugs that may interfere with the skin reactions.
• Pregnancy, dermographism, atopic dermatitis (locally at the test site), urticaria.
• Any disease which prohibits the use of adrenaline (hyperthyroidism, arterial hypertension, cardiopathy, etc.)
• Lack of cooperation which may interfere with the study, or subjects with severe psychiatric, psychological or neurological disorders.

Sponsors & Collaborators

• Laboratorios Leti, S.L.: lead

Study Sites (1)

Clinica Dr. Lobatón

Cadiz, Cadiz, 11008, Spain

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Study Officials

• Francisco Moreno, MD, PhD

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 10, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 20, 2011

Record last verified: 2011-06

Locations

ES (1)