Status:
COMPLETED
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen
Lead Sponsor:
Laboratorios Leti, S.L.
Conditions:
Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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 (wi...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT00831025
Start Date
January 1 2008
End Date
January 1 2013
Last Update
February 23 2018
Active Locations (7)
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1
Hospital El Tomillar
Dos Hermanas, Sevilla, Spain, 41700
2
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004
3
Hospital Universitario San Cecilio
Granada, Spain, 18012
4
Complejo Hospitalario de Jaén
Jaén, Spain, 23007