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Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen (OLEA)

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ClinicalTrials.gov Identifier: NCT00831025
Recruitment Status : Completed
First Posted : January 28, 2009
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Laboratorios Leti, S.L.

January 27, 2009
January 28, 2009
February 23, 2018
January 2008
January 2013   (Final data collection date for primary outcome measure)
Symptoms and medication score [ Time Frame: 2 years ]
Symptoms score [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00831025 on ClinicalTrials.gov Archive Site
  • Dose-response skin prick-test [ Time Frame: 2 years ]
  • Medication score [ Time Frame: 2 years ]
  • Rhinoconjunctivitis quality of life questionnaire [ Time Frame: 2 years ]
  • Visual Analog Scales (VAS) [ Time Frame: 2 years ]
  • Serology [ Time Frame: 2 years ]
  • Symptoms score [ Time Frame: 2 years ]
  • Exhaled nitric oxide [ Time Frame: 2 years ]
  • Adverse event [ Time Frame: 2 years ]
  • Dose-response skin prick-test [ Time Frame: 2 years ]
  • Medication score [ Time Frame: 2 years ]
  • Rhinoconjunctivitis quality of life questionnaire [ Time Frame: 2 years ]
  • Analogical visual scale [ Time Frame: 2 years ]
  • Serology [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Olea Europaea Pollen
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
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Rhinitis or Rhinoconjunctivitis With or Without Asthma Induced by Hypersensitivity to Olea Europea Pollen
  • Biological: Immunotherapy with modified extract of Olea europaea pollen
    Subcutaneous immunotherapy with modified extract of Olea europaea. A subcutaneous monthly treatment.
  • Biological: Placebo
    Placebo for subcutaneous monthly administration
  • Experimental: 1
    Depigmented and polymerized allergen extract of Olea europaea pollen for subcutaneous injection.
    Intervention: Biological: Immunotherapy with modified extract of Olea europaea pollen
  • Placebo Comparator: 2
    Placebo for subcutaneous injection.
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
158
150
January 2013
January 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00831025
6018-PG-PSC-148
2006-005727-41 ( EudraCT Number )
No
Not Provided
Not Provided
Laboratorios Leti, S.L.
Laboratorios Leti, S.L.
Not Provided
Principal Investigator: Pedro Guardia, MD
Laboratorios Leti, S.L.
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP