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OpenTrials
Completed

NCT Number: NCT00537342

Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)

The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Olea europaea in the rhinitis or allergic rhinoconjunctivitis

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitatio Ciudad de Jaén

Jaén, 23007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Positive suggestive clinical history of allergic seasonal rhinitis or rhinoconjunctivitis
  • Patients of both gender > 18 years old
  • Positive prick test results using non modified Olea europaea allergen extract (wheal size > 3mm2)
  • Specific IgE to Olea europaea
  • Written informed consent

Exclusion criteria

  • Use of immunotherapy during the last four years.
  • Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
  • Treatment with ß-blockers
  • Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
  • Patients suffering from immune deficiencies
  • Patients with serious psychiatric / psychological disturbances
  • In addition, the following was considered as exclusion criteria:
  • Pregnant or/ in lactation patients
  • Patients aspirin intolerance

Treatment and study plan

Immunotherapy with modified extract of O. europaea pollen

Biological

Sublingual (2 drops daily during 2 months)

Primary outcomes

  1. Symptom score

    Time frame: 1 year

Secondary outcomes

  1. Dose-response skin prick-test

    Time frame: 1 year

  2. Medication score

    Time frame: 1 year

  3. Rhinoconjunctivitis quality of life questionnaire

    Time frame: 1 year

  4. Analogical visual scale

    Time frame: 1 year

  5. Serology

    Time frame: 1 year

  6. Record of adverse events

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Laboratorios Leti, S.L.

Industry

Registry information

Official study title

Prospective, Randomised, Double Blind, Placebo Controlled Study of Treatment With Sublingual Immunotherapy of Depigmented and Polymerised Allergen Extract of O. Europaea in Two Groups of Patients With Allergic Rhinitis /Rhinoconjunctivitis

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 1, 2007
Registry last updated
Dec 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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