Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

Phase 2

Completed

• Conditions: Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic; Asthma
• Interventions: Biological: Immunotherapy with modified extract of P. pratense pollen; Other: Placebo

• Registration Number: NCT00501527
• Lead Sponsor: Laboratorios Leti, S.L.

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.

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 Timeline

• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-16
• Study Start: 2007-09
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-16
• Last Update Posted: 2010-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: Biological vaccine	Immunotherapy with modified extract of P. pratense pollen	The first active arm will receive a dose that is 10x less than the dose of the other arm
B: biological vaccine	Immunotherapy with modified extract of P. pratense pollen	The first active arm will receive a dose that is 10x more than the dose of the other arm
C	Placebo	-

Primary Outcome Measures

Name	Time	Method
Symptom scores	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Clínico de Salamanca; 🇪🇸 Salamanca, Spain