Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

Study Overview
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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).

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

Conditions
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Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic, Asthma

Intervention / Treatment
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* Biological: Immunotherapy with modified extract of P. pratense pollen
* Other: Placebo


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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Biological vaccine<br>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<br>* Sublingual (2 drops daily)<br>|
| Experimental: B: biological vaccine<br>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<br>* Sublingual (2 drops daily)<br>|
| Placebo Comparator: C<br> | Other: Placebo<br>* Placebo 2 drops daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom scores |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depigmented, Allergoid, Polymerized, Allergen-extract, Rhinoconjunctivitis, Asthma