ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00917488
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : June 20, 2011
Sponsor:
Information provided by:
Laboratorios Leti, S.L.

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

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Conjunctivitis, Allergic Other: Standardization of allergenic extract (Gly. domesticus) Phase 2

Detailed 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".


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Glycyphagus Domesticus Allergen Extract. Determination of the in Vivo Biological Activity in Histamine Equivalent Units (HEP).
Study Start Date : May 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
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)
Allergenic extract for cutaneous prick-test



Primary Outcome Measures :
  1. Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. [ Time Frame: 45 minutes per subject ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917488


Locations
Spain
Clinica Dr. Lobatón
Cádiz, Cadiz, Spain, 11008
Sponsors and Collaborators
Laboratorios Leti, S.L.
Investigators
Principal Investigator: Francisco Moreno, MD, PhD

Responsible Party: María José Gómez / Clinical Development Manager, Laboratorios LETI S.L.Unipersonal
ClinicalTrials.gov Identifier: NCT00917488     History of Changes
Other Study ID Numbers: 108-PR-PRI-147
2007-000904-33 ( EudraCT Number )
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: June 2011

Keywords provided by Laboratorios Leti, S.L.:
Allergen extract Standardization

Additional relevant MeSH terms:
Rhinitis
Conjunctivitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Conjunctivitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Conjunctival Diseases
Eye Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs