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Biological Standardization of Platanus Acerifolia Allergen Extract

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:
NCT01739322
First received: November 29, 2012
Last updated: November 8, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Allergy to Platanus Acerifolia.
Biological: Prick test Platanus acerifolia allergen extract
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Biological Standardization of Platanus Acerifolia Allergen Extract to Determine the Biological Activity in HEP Units.

Resource links provided by NLM:


Further study details as provided by Laboratorios Leti, S.L.:

Primary Outcome Measures:
  • Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. [ Time Frame: Test sites should be inspected and recorded 15-20 min after application ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Four concentrations of Platanus acerifolia allergen extract (10, 1, 0.1, 0.01 mg/ml)

Positive control (10 mg/ml histamine dihydrochloride)

Negative control (glycerinated phenol saline solution)

Biological: Prick test Platanus acerifolia allergen extract

This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines.

Four concentrations of Platanus acerifolia 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. This test will be referred to as the Titrated Skin Prick test.

Other Name: Platanus acerifolia allergen extract.

Detailed 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 Platanus acerifolia 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Age > and =18 years and < and =60 years at the study inclusion day.
  • Positive skin prick test with a standardized commercially available preparation of Platanus acerifolia allergen extract. The skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm or an area at least 7 mm2. Positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study
  • A positive test for specific IgE to Platanus acerifolia (CAP-RAST major or equal to 2). IgE results are valid if performed within oneyear prior to the inclusion of the subject in the study.
  • Allergic symptoms during the pollen season of Platanus acerifolia.
  • Medical history positive allergy inhalation (rhinitis and /or rhinoconjunctivitis and/or asthma) from Platanus acerifolia.

Exclusion Criteria:

  • Immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested due to a high degree of cross-reactivity (for example:other species of Platanus: Platanus orientalis, Platanus occidentalis).
  • 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.
  • Participation in any other clinical trial within 30 days (or 5 times the biological half-life of the research of the study product, whichever is longer) prior to the inclusion of the subject in this clinical trial.
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739322

Locations
Spain
Hospital Clinic
Barcelona, Spain, 08036
Hospital Universitario Gregorio Marañón
Madrid, Spain, 28007
Sponsors and Collaborators
Laboratorios Leti, S.L.
  More Information

No publications provided

Responsible Party: Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier: NCT01739322     History of Changes
Other Study ID Numbers: 6022-PR-PRI-194
Study First Received: November 29, 2012
Last Updated: November 8, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Histamine
Histamine phosphate
Histamine Agents
Histamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014