Clinical trial NCT00831025: Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen
Official title: Multicenter, Randomised, Double-blind Placebo-controlled, Subcutaneous Immunotherapy Clinical Trial With Depigmented and Polymerized Allergen Extract of Olea Europaea Pollen in Patients With Hypersensitivity to Olea Pollen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen
Keywords: Immunotherapy
Allergoid
Depigmented
Polymerized
Allergen-extract
Rhinoconjunctivitis
Lead sponsor: Laboratorios Leti, S.L.
Sponsor class: INDUSTRY
First posted: 2009-01-28
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this trial is to assess the clinical efficacy of a modified allergen extract of Olea europaea pollen in the treatment of patients affected by allergic rhinitis/rhinoconjunctivitis (with or without episodic asthma) induced by hypersensitivity to olea europaea pollen, evaluating the Score regarding Symptoms and consumption of the medication.

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 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 europaea pollen. The IgE mediated sensitization has to be verified by:
* Suggestive medical history
* Specific IgE against Olea europaea 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.

Exclusion Criteria

* 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

Primary outcomes:
measure: Symptoms and medication score
timeFrame: 2 years
Secondary outcomes:
measure: Dose-response skin prick-test
timeFrame: 2 years
measure: Medication score
timeFrame: 2 years
measure: Rhinoconjunctivitis quality of life questionnaire
timeFrame: 2 years
measure: Visual Analog Scales (VAS)
timeFrame: 2 years
measure: Serology
timeFrame: 2 years
measure: Symptoms score
timeFrame: 2 years
measure: Exhaled nitric oxide
timeFrame: 2 years
measure: Adverse event
timeFrame: 2 years
Other outcomes:
Locations:
city: Dos Hermanas
country: Spain
facility: Hospital El Tomillar
state: Sevilla
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Sevilla
country: Spain
facility: Clínica Santa Isabel
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
Study officials:
name: Pedro Guardia, MD
role: PRINCIPAL_INVESTIGATOR
References: