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

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. Identifier: NCT00622362
Recruitment Status : Suspended (Lack of recruitment)
First Posted : February 25, 2008
Last Update Posted : February 22, 2018
Information provided by (Responsible Party):
Laboratorios Leti, S.L.

Brief Summary:
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 or disease Intervention/treatment Phase
Allergic Asthma Biological: DEPIGOID Dermatophagoides pteronyssinus Biological: Polymerized TOL of Dermatophagoides pteronyssinus Biological: Placebo Comparator Phase 2

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : January 2008
Actual Primary Completion Date : February 2009
Study Completion Date : March 24, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Symptom and medication scores [ Time Frame: 1 year per patient ]

Secondary Outcome Measures :
  1. 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 ]
  2. Quality of life [ Time Frame: 1 year ]
  3. Cost-effectiveness [ Time Frame: 1 year ]
  4. Dose response prick-test [ Time Frame: 1 year ]
  5. Inflammatory markers [ Time Frame: 1 year ]
  6. Use of health resources [ Time Frame: 1 year ]

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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00622362

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

Responsible Party: Laboratorios Leti, S.L. Identifier: NCT00622362     History of Changes
Other Study ID Numbers: 2006-000571-15
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Keywords provided by Laboratorios Leti, S.L.:

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