Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen
Conditions
Keywords
Immunotherapy, Allergoid, Depigmented, Polymerized, Allergen-extract, Rhinoconjunctivitis
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.
Interventions
BIOLOGICALImmunotherapy with modified extract of Olea europaea pollen
Subcutaneous immunotherapy with modified extract of Olea europaea. A subcutaneous monthly treatment.
BIOLOGICALPlacebo
Placebo for subcutaneous monthly administration
Sponsors
Laboratorios Leti, S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms and medication score | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Exhaled nitric oxide | 2 years |
| Adverse event | 2 years |
| Dose-response skin prick-test | 2 years |
| Symptoms score | 2 years |
| Rhinoconjunctivitis quality of life questionnaire | 2 years |
| Visual Analog Scales (VAS) | 2 years |
| Serology | 2 years |
| Medication score | 2 years |
Countries
Spain
Outcome results
None listed