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

January 10, 2008
January 27, 2009
January 2008
December 2009   (final data collection date for primary outcome measure)
Symptom and medication scores [ Time Frame: 1 year per patient ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00622362 on ClinicalTrials.gov 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 ] [ 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 ]
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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
90
December 2009
December 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
Both
5 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00622362
2006-000571-15, 101-PG-COM-143
No
María José Gómez., Laboratorios LETI S.L. Unipersonal
Laboratorios Leti, S.L.
Not Provided
Principal Investigator: Antonio Nieto, MD PhD
Laboratorios Leti, S.L.
January 2009

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