Back to resultsSubcutaneous-Sublingual Immunotherapy With Depigmented and Polymerized Dermatophagoides Pteronyssinus Allergen Extract
Primary Purpose
Allergic Asthma
Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
DEPIGOID Dermatophagoides pteronyssinus
Polymerized TOL of Dermatophagoides pteronyssinus
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Asthma focused on measuring Immunotherapy, Allergy, Allergoid, Depigmented, Polymerized, Allergen-extract, mites, Asthma
Eligibility 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
Sites / Locations
- Hospital Universitario La Fé
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
A
B
C
Arm Description
Subcutaneous administration
Sublingual administration
Sublingual administration
Outcomes
Primary Outcome Measures
Symptom and medication scores
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
QoL
The Paediatric Asthma Quality of Life Questionnaire (PAQLQ) was developed to measure the functional problems (physical, emotional and social) that are most troublesome to children with asthmaQuestionnaire" E. Juniper
Cost-effectiveness
Dose response prick-test
Inflammatory markers
Use of health resources
Full Information
NCT ID
NCT00622362
First Posted
January 10, 2008
Last Updated
March 6, 2019
Sponsor
Laboratorios Leti, S.L.
1. Study Identification
Unique Protocol Identification Number
NCT00622362
Brief Title
Subcutaneous-Sublingual Immunotherapy With Depigmented and Polymerized Dermatophagoides Pteronyssinus Allergen Extract
Official Title
Depigmented and Polymerised Allergenic Extract of Dermatophagoides Pteronyssinus as Antiasthmatic Treatment for Children With Slight Allergic Asthma to Mites
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
January 2008 (Actual)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratorios Leti, S.L.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Asthma
Keywords
Immunotherapy, Allergy, Allergoid, Depigmented, Polymerized, Allergen-extract, mites, Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Subcutaneous administration
Arm Title
B
Arm Type
Experimental
Arm Description
Sublingual administration
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
Sublingual administration
Intervention Type
Biological
Intervention Name(s)
DEPIGOID Dermatophagoides pteronyssinus
Intervention Description
Subcutaneous administration:0.5 ml/month during 1 year
Intervention Type
Biological
Intervention Name(s)
Polymerized TOL of Dermatophagoides pteronyssinus
Intervention Description
Sublingual immunotherapy. Two drops daily during 1 year
Intervention Type
Biological
Intervention Name(s)
Placebo Comparator
Intervention Description
Sublingual immunotherapy. Two drops daily during 1 year
Primary Outcome Measure Information:
Title
Symptom and medication scores
Time Frame
1 year per patient
Secondary Outcome Measure Information:
Title
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
Title
QoL
Description
The Paediatric Asthma Quality of Life Questionnaire (PAQLQ) was developed to measure the functional problems (physical, emotional and social) that are most troublesome to children with asthmaQuestionnaire" E. Juniper
Time Frame
1 year
Title
Cost-effectiveness
Time Frame
1 year
Title
Dose response prick-test
Time Frame
1 year
Title
Inflammatory markers
Time Frame
1 year
Title
Use of health resources
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Nieto, MD PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Fé
City
Valencia
ZIP/Postal Code
46009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Subcutaneous-Sublingual Immunotherapy With Depigmented and Polymerized Dermatophagoides Pteronyssinus Allergen Extract
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