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Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

This study has been completed.
Sponsor:
Information provided by:
Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:
NCT00501527
First received: July 13, 2007
Last updated: December 16, 2010
Last verified: December 2010
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laboratorios Leti, S.L.:

Primary Outcome Measures:
  • Symptom scores [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nasal provocation test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Dose-response skin prick-test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Medication scores [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Visual scales [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • "In vitro" immunological tests [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Record of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: September 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501527

Locations
Spain
Hospital Clínico de Salamanca
Salamanca, Spain, 37007
Sponsors and Collaborators
Laboratorios Leti, S.L.
Investigators
Principal Investigator: Félix Lorente, Prf. PhD
  More Information

No publications provided

Responsible Party: Mª José Gómez, Laboratorios LETI S.L.Unipersonal
ClinicalTrials.gov Identifier: NCT00501527     History of Changes
Other Study ID Numbers: 2006-001437-18, 6078-PG-OSL-145
Study First Received: July 13, 2007
Last Updated: December 16, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Laboratorios Leti, S.L.:
Allergoid
Depigmented
Polymerized
 Allergen-extract
Rhinoconjunctivitis
Asthma

Additional relevant MeSH terms:
Asthma
Conjunctivitis
Conjunctivitis, Allergic
Rhinitis, Allergic, Seasonal
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 16, 2013