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Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

NCT ID: NCT00501527

Last Updated: 2010-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-10-31

Brief Summary

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The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Phleum pratense in the rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass pollen.

Detailed Description

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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 three arms of treatment: placebo and two active (one of the active arms will receive a dose that is 10x the dose of the other arm).

Conditions

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Rhinitis, Allergic, Seasonal Conjunctivitis, Allergic Asthma

Keywords

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Allergoid Depigmented Polymerized Allergen-extract Rhinoconjunctivitis Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A: Biological vaccine

The first active arm will receive a dose that is 10x less than the dose of the other arm

Group Type EXPERIMENTAL

Immunotherapy with modified extract of P. pratense pollen

Intervention Type BIOLOGICAL

Sublingual (2 drops daily)

B: biological vaccine

The first active arm will receive a dose that is 10x more than the dose of the other arm

Group Type EXPERIMENTAL

Immunotherapy with modified extract of P. pratense pollen

Intervention Type BIOLOGICAL

Sublingual (2 drops daily)

C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo 2 drops daily

Interventions

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Immunotherapy with modified extract of P. pratense pollen

Sublingual (2 drops daily)

Intervention Type BIOLOGICAL

Placebo

Placebo 2 drops daily

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Positive clinical history of allergy to Phleum pratense
* Patients of both gender aged from 12 up to 50 years.
* Positive prick test to Phleum pratense allergen extracts
* Specific IgE to Phleum pratense
* Positive clinical history of allergic rhinoconjunctivitis and/or asthma
* 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
* Pregnant or/ in lactation patients
* Patients aspirin intolerance
Minimum Eligible Age

12 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratorios Leti, S.L.

INDUSTRY

Sponsor Role lead

Responsible Party

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Laboratorios LETI S.L.Unipersonal

Principal Investigators

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Félix Lorente, Prf. PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clínico de Salamanca

Salamanca, Salamanca, Spain

Site Status

Countries

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Spain

Other Identifiers

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6078-PG-OSL-145

Identifier Type: OTHER

Identifier Source: secondary_id

2006-001437-18

Identifier Type: -

Identifier Source: org_study_id