Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

Sponsor

Laboratorios Leti, S.L. (Industry)

Overall Status

Completed

CT.gov ID

NCT00501527

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic, Seasonal Conjunctivitis, Allergic Asthma	Biological: Immunotherapy with modified extract of P. pratense pollen Other: Placebo	Phase 2

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 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense in Patients Suffering From Allergic Rhinoconjunctivitis and/or Asthma

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A: Biological vaccine The first active arm will receive a dose that is 10x less than the dose of the other arm	Biological: Immunotherapy with modified extract of P. pratense pollen Sublingual (2 drops daily)
Experimental: B: biological vaccine The first active arm will receive a dose that is 10x more than the dose of the other arm	Biological: Immunotherapy with modified extract of P. pratense pollen Sublingual (2 drops daily)
Placebo Comparator: C	Other: Placebo Placebo 2 drops daily

Arm

Intervention/Treatment

Experimental: A: Biological vaccine

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

Biological: Immunotherapy with modified extract of P. pratense pollen

Sublingual (2 drops daily)

Experimental: B: biological vaccine

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

Biological: Immunotherapy with modified extract of P. pratense pollen

Sublingual (2 drops daily)

Placebo Comparator: C

Other: Placebo

Placebo 2 drops daily

Outcome Measures

Primary Outcome Measures

Symptom scores [1 year]

Secondary Outcome Measures

Nasal provocation test [1 year]
Dose-response skin prick-test [1 year]
Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ) [1 year]
Medication scores [1 year]
Visual scales [1 year]
"In vitro" immunological tests [1 year]
Record of adverse events [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
In addition, the following was considered as exclusion criteria:
Pregnant or/ in lactation patients
Patients aspirin intolerance