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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 08, 2014