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.

January 10, 2008
February 25, 2008
February 22, 2018
January 2008
February 2009   (Final data collection date for primary outcome measure)
Symptom and medication scores [ Time Frame: 1 year per patient ]
Same as current
Complete list of historical versions of study NCT00622362 on Archive Site
  • 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 ]
  • Quality of life [ Time Frame: 1 year ]
  • Cost-effectiveness [ Time Frame: 1 year ]
  • Dose response prick-test [ Time Frame: 1 year ]
  • Inflammatory markers [ Time Frame: 1 year ]
  • Use of health resources [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
Subcutaneous-Sublingual Immunotherapy With Depigmented and Polymerized Dermatophagoides Pteronyssinus Allergen Extract
Depigmented and Polymerised Allergenic Extract of Dermatophagoides Pteronyssinus as Antiasthmatic Treatment for Children With Slight Allergic Asthma to Mites
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
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).
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Allergic Asthma
  • Biological: DEPIGOID Dermatophagoides pteronyssinus
    Subcutaneous administration:0.5 ml/month during 1 year
  • Biological: Polymerized TOL of Dermatophagoides pteronyssinus
    Sublingual immunotherapy. Two drops daily during 1 year
  • Biological: Placebo Comparator
    Sublingual immunotherapy. Two drops daily during 1 year
  • Active Comparator: A
    Subcutaneous administration
    Intervention: Biological: DEPIGOID Dermatophagoides pteronyssinus
  • Experimental: B
    Sublingual administration
    Intervention: Biological: Polymerized TOL of Dermatophagoides pteronyssinus
  • Placebo Comparator: C
    Sublingual administration
    Intervention: Biological: Placebo Comparator
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 24, 2014
February 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 14 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Laboratorios Leti, S.L.
Laboratorios Leti, S.L.
Not Provided
Principal Investigator: Antonio Nieto, MD PhD
Laboratorios Leti, S.L.
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP