Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen Clinical Trial
— OLEAOfficial 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
| Verified date | February 2018 |
| Source | Laboratorios Leti, S.L. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 158 |
| Est. completion date | January 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility |
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 ß-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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario Reina Sofía | Córdoba | |
| Spain | Hospital El Tomillar | Dos Hermanas | Sevilla |
| Spain | Hospital Universitario San Cecilio | Granada | |
| Spain | Complejo Hospitalario de Jaén | Jaén | |
| Spain | Clínica Santa Isabel | Sevilla | |
| Spain | Hospital Universitario Virgen Del Rocio | Sevilla | |
| Spain | Hospital Virgen Macarena | Sevilla |
| Lead Sponsor | Collaborator |
|---|---|
| Laboratorios Leti, S.L. |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Symptoms and medication score | 2 years | ||
| Secondary | Dose-response skin prick-test | 2 years | ||
| Secondary | Medication score | 2 years | ||
| Secondary | Rhinoconjunctivitis quality of life questionnaire | 2 years | ||
| Secondary | Visual Analog Scales (VAS) | 2 years | ||
| Secondary | Serology | 2 years | ||
| Secondary | Symptoms score | 2 years | ||
| Secondary | Exhaled nitric oxide | 2 years | ||
| Secondary | Adverse event | 2 years |