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Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00501527
First Posted: July 16, 2007
Last Update Posted: December 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Laboratorios Leti, S.L.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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

Primary Outcome Measures:
  • Symptom scores [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Nasal provocation test [ Time Frame: 1 year ]
  • Dose-response skin prick-test [ Time Frame: 1 year ]
  • Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ) [ Time Frame: 1 year ]
  • Medication scores [ Time Frame: 1 year ]
  • Visual scales [ Time Frame: 1 year ]
  • "In vitro" immunological tests [ Time Frame: 1 year ]
  • Record of adverse events [ Time Frame: 1 year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: Sponsor Protocol number )
First Submitted: July 13, 2007
First Posted: July 16, 2007
Last Update Posted: December 17, 2010
Last Verified: December 2010

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

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