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Main
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Note: This record shows only 22 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00537342 |
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Date of registration:
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28/09/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)
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Scientific title:
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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 |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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83 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00537342 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Spain
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Contacts
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Name:
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Juan Luis Anguita, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Rhinoconjunctivitis
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Allergy
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Intervention(s)
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Biological: Immunotherapy with modified extract of O. europaea pollen
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Primary Outcome(s)
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Symptom score
[Time Frame: 1 year]
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Secondary Outcome(s)
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Medication score
[Time Frame: 1 year]
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Dose-response skin prick-test
[Time Frame: 1 year]
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Record of adverse events
[Time Frame: 1 year]
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Rhinoconjunctivitis quality of life questionnaire
[Time Frame: 1 year]
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Analogical visual scale
[Time Frame: 1 year]
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Serology
[Time Frame: 1 year]
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Secondary ID(s)
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6018-PG-OSL-142
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2006-001130-41
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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