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Subcutaneous-Sublingual Immunotherapy With Depigmented and Polymerized Dermatophagoides Pteronyssinus Allergen Extract

This study has suspended participant recruitment.
(Lack of recruitment)
Sponsor:
Information provided by:
Laboratorios Leti, S.L.
ClinicalTrials.gov Identifier:
NCT00622362
First received: January 10, 2008
Last updated: January 27, 2009
Last verified: January 2009
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 Dermatophagoides pteronyssinus in children with allergic asthma due to this mite


Condition Intervention Phase
Allergic Asthma
 Biological: DEPIGOID Dermatophagoides pteronyssinus
Biological: Polymerized TOL of Dermatophagoides pteronyssinus
Biological: Placebo Comparator
 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: Depigmented and Polymerised Allergenic Extract of Dermatophagoides Pteronyssinus as Antiasthmatic Treatment for Children With Slight Allergic Asthma to Mites

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

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

Secondary Outcome Measures:
  • Comparison between sublingual and subcutaneous administration route, quality of life, cost-effectiveness, dose response prick-test, inflammatory markers, exhaled nitric oxide, inflammatory markers in exhalate bronchial condensate, use of health resources [ Time Frame: 1 year per patient ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cost-effectiveness [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Dose response prick-test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Use of health resources [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Subcutaneous administration
 Biological: DEPIGOID Dermatophagoides pteronyssinus
Subcutaneous administration:0.5 ml/month during 1 year
Experimental: B
Sublingual administration
 Biological: Polymerized TOL of Dermatophagoides pteronyssinus
Sublingual immunotherapy. Two drops daily during 1 year
Placebo Comparator: C
Sublingual administration
 Biological: Placebo Comparator
Sublingual immunotherapy. Two drops daily during 1 year

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 subcutaneous immunotherapy and the other one will receive sublingual immunotherapy).

  Eligibility

Ages Eligible for Study:   5 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent signed by the patient and guardian.
  • Positive clinical history of allergy to dust mites.
  • FEV1 greater than or equal to 80% of the expected value and improvement in FEV1 greater than 12% after bronchodilation.
  • Age-between 5 and 14 years.
  • Sensitization to dust mites, diagnosed by positive skin tests to Dermatophagoides pteronyssinus: wheal size > 3 mm diameter and / or RAST (> 0.7 kU / L).

Exclusion Criteria:

  • Patients out of the age range.
  • 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
    • Patients who have a condition in which adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc..).
    • 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
  • Patients aspirin intolerance
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622362

Locations
Spain
Hospital Universitario La Fé
Valencia, Spain, 46009
Sponsors and Collaborators
Laboratorios Leti, S.L.
Investigators
Principal Investigator: Antonio Nieto, MD PhD
  More Information

No publications provided

Responsible Party: María José Gómez., Laboratorios LETI S.L. Unipersonal
ClinicalTrials.gov Identifier: NCT00622362     History of Changes
Other Study ID Numbers: 2006-000571-15, 101-PG-COM-143
Study First Received: January 10, 2008
Last Updated: January 27, 2009
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013