Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic
• Intervention / Treatment: Biological: Immunotherapy with modified extract of P. pratense pollen; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Hospital Clinico de Salamanca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: C	Other: Placebo; Placebo 2 drops daily
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Symptom scores	1 year

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Laboratorios Leti, S.L.
• Investigators: Principal Investigator: Félix Lorente, Prf. PhD

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: July 13, 2007
• First Submitted That Met QC Criteria: July 13, 2007
• First Posted (Estimate): July 16, 2007

Study Record Updates

• Last Update Posted (Estimate): December 17, 2010
• Last Update Submitted That Met QC Criteria: December 16, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Asthma; Rhinoconjunctivitis; Allergoid; Depigmented; Polymerized; Allergen-extract
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Eye Diseases; Bronchial Diseases; Otorhinolaryngologic Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Conjunctival Diseases; Asthma; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID Numbers: 2006-001437-18; 6078-PG-OSL-145 (Other Identifier: Sponsor Protocol number)