Olea Europaea Subcutaneous Immunotherapy - Full Text View

Sponsored by:	Laboratorios Leti, S.L.
Information provided by:	Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:	NCT00831025

Purpose

The purpose of this study is to determine whether depigmented and polymerized allergen extract of olea europaea pollen via subcutaneous injection is effective in the treatment of allergic patients with rhinitis/rhinoconjunctivitis symptoms due to this pollen.

Condition	Intervention	Phase
Allergy Rhinoconjunctivitis	Biological: Immunotherapy with modified extract of O europaea pollen	Phase III

MedlinePlus related topics: Allergy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter, Randomized, Double-Blind Placebo-Controlled Study, Subcutaneous Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea Pollen in Hypersensitivity Patients to This Pollen

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

Primary Outcome Measures:

Symptoms score [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Dose-response skin prick-test [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Medication score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Rhinoconjunctivitis quality of life questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Analogical visual scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Serology [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Depigmented and polymerized allergen extract of olea europea pollen	Biological: Immunotherapy with modified extract of O europaea pollen Subcutaneous injection
B: Placebo Comparator Placebo	Biological: Immunotherapy with modified extract of O europaea pollen Subcutaneous injection

Detailed Description:

Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with two arms of treatment: placebo and active.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Prior to study specific examinations the patient and if applicable both legal guardians has to give his/her written informed consent
Patients of both gender aged from 18 and 55 years
Patient`s perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS)
FEV1 greater or equal than 80% of the expected value, and if not, improvement of FEV1 greater than 12% after bronchodilation
Patients have to suffer from allergic complaints (rhinitis and/or rhinoconjunctivitis with or without mild intermittent allergic asthma) caused by clinical sensitization against olea europea pollen. The IgE mediated sensitization has to be verified by:
Suggestive medical history
Specific IgE against olea europea pollen CAP RAST ≥0.7Ku/l
Positive skin prick test (SPT) to grass olea pollen resulting in a wheal diameter of at least 3 mm.

Criteria for Exclusion

History of significant clinical manifestations of allergy as a result of sensitization against weed pollen allergens and perennial (e.g. house dust mite.
Participation in an immunotherapy with comparable extracts within the last five years.
Treatment with β-blocker
Any disease which prohibits the use of adrenaline (e.g. hyperthyroidism)
Cardiovascular insufficiency or any severe or unstable pulmonary, or endocrine disease; clinically significant renal or hepatic disease or dysfunction; hematologic disorder; any other clinically significant medical condition that could increase the risk to the study participant
Immunopathological diseases
Patients who are expected to be non-compliant and/or not co-operative
Women, where pregnancy is defined as the state of a female after conception and until the termination of gestation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00831025

Contacts

Contact: Carlos Badiola, Doctor

0034 91 771 17 90

cbadiola@leti.com

Locations

Spain
Hospital Universitario Virgen Del Rocio	Recruiting
Sevilla, Spain, 41013
Principal Investigator: Teresa González-Quevedo, MD
Clínica Santa Isabel	Not yet recruiting
Sevilla, Spain, 41018
Principal Investigator: Amparo Conde, MD
Clínica de Fátima	Not yet recruiting
Sevilla, Spain, 41012
Principal Investigator: Stephan Cimbollek, MD
Hospital Universitario San Cecilio	Not yet recruiting
Granada, Spain, 18012
Principal Investigator: Fernando Florido, MD
Hospital Nuestra SEÑORA De La Salud	Not yet recruiting
Granada, Spain, 18014
Principal Investigator: Julian López Caballero, MD
Hospital Universitario Reina Sofía	Not yet recruiting
Córdoba, Spain, 14004
Principal Investigator: Francisco Guerra, MD
Hospital Virgen Macarena	Recruiting
Sevilla, Spain, 41071
Principal Investigator: Pedro Guardia, MD
Spain, Sevilla
Hospital El Tomillar	Recruiting
Dos Hermanas, Sevilla, Spain, 41700
Principal Investigator: Ana Navarro, MD

Sponsors and Collaborators

Laboratorios Leti, S.L.

Investigators

Principal Investigator:

Pedro Guardia, MD

Unaffiliated

More Information

No publications provided

Responsible Party:	Laboratorios LETI S.L.Unipersonal ( Carlos Badiola )
Study ID Numbers:	2006-005727-41
Study First Received:	January 27, 2009
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00831025 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Laboratorios Leti, S.L.:

Immunotherapy
Allergoid
Depigmented

Polymerized
Allergen-extract
Rhinoconjunctivitis

Study placed in the following topic categories:

Hypersensitivity
Eye Diseases
Conjunctivitis
Conjunctival Diseases

Additional relevant MeSH terms:

Eye Diseases
Conjunctivitis
Conjunctival Diseases

ClinicalTrials.gov processed this record on May 06, 2009