Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

Leti Pharma

Status and phase: Completed; Phase 2

Conditions: Asthma; Conjunctivitis, Allergic; Rhinitis, Allergic, Seasonal

Treatments: Other: Placebo; Biological: Immunotherapy with modified extract of P. pratense pollen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00501527

6078-PG-OSL-145 (Other Identifier)

2006-001437-18

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 patients

Sex: All

Ages: 12 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 3 patient groups, including a placebo group

A: Biological vaccine

Experimental group

Description:

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

Treatment:

Biological: Immunotherapy with modified extract of P. pratense pollen

B: biological vaccine

Experimental group

Description:

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

Treatment:

Biological: Immunotherapy with modified extract of P. pratense pollen

C

Placebo Comparator group

Treatment:

Other: Placebo