CompletedNCT00537342Updated Dec 17, 2010

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

A Phase 3 interventional study of Immunotherapy with modified extract of O. europaea pollen in Allergy and Rhinoconjunctivitis, sponsored by Laboratorios Leti, S.L.. Completed at 1 site in Spain. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2010-12-17.

Sponsored by Laboratorios Leti, S.L. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 83
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Allergy
Rhinoconjunctivitis

Browse trials for

Conjunctivitis 361

Keywords

Immunotherapy
Allergoid
Depigmented
Polymerized
Allergen-extract
Rhinoconjunctivitis

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 83 is below the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Laboratorios Leti, S.L. is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 83 participants (actual)

Study arms

Experimental
A
Biological Vaccine
Biological: Immunotherapy with modified extract of O. europaea pollen
Placebo comparator
B
Biological: Immunotherapy with modified extract of O. europaea pollen

Interventions

BiologicalImmunotherapy with modified extract of O. europaea pollen
Sublingual (2 drops daily during 2 months)

What researchers measure

Primary outcomes

Symptom score
Time frame: 1 year

Secondary outcomes

Dose-response skin prick-test
Time frame: 1 year
Medication score
Time frame: 1 year
Rhinoconjunctivitis quality of life questionnaire
Time frame: 1 year
Analogical visual scale
Time frame: 1 year
Serology
Time frame: 1 year
Record of adverse events
Time frame: 1 year

Study locations

1 site

Hospital Universitatio Ciudad de Jaén
Jaén, 23007, Spain

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 17, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00537342
Lead sponsor: Laboratorios Leti, S.L.
First posted: Oct 1, 2007
Start date: Oct 2007
Primary completion: Sep 2009
Completion: Dec 2009
Last update: Dec 17, 2010

Study contacts

Juan Luis Anguita, MD

principal investigator

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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