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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00537342
Date of registration: 28/09/2007
Primary sponsor: Laboratorios Leti, S.L.
Public title: Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)
Scientific 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
Date of first enrolment: October 2007
Target sample size: 83
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00537342
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Countries of recruitment
Spain
Contacts
Name:   Juan Luis Anguita, MD
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Allergy
Rhinoconjunctivitis
Intervention(s)
Biological: Immunotherapy with modified extract of O. europaea pollen
Primary Outcome(s)
Symptom score [Time Frame: 1 year]
Secondary Outcome(s)
Analogical visual scale [Time Frame: 1 year]
Dose-response skin prick-test [Time Frame: 1 year]
Medication score [Time Frame: 1 year]
Record of adverse events [Time Frame: 1 year]
Rhinoconjunctivitis quality of life questionnaire [Time Frame: 1 year]
Serology [Time Frame: 1 year]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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