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| ID | Type | Description | Link |
|---|---|---|---|
| 101-PG-COM-143 |
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Lack of recruitment
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Subcutaneous administration |
|
| B | Experimental | Sublingual administration |
|
| C | Placebo Comparator | Sublingual administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEPIGOID Dermatophagoides pteronyssinus | Biological | Subcutaneous administration:0.5 ml/month during 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptom and medication scores | 1 year per patient |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year per patient | |
| QoL |
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Inclusion Criteria:
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:
Patients aspirin intolerance
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Nieto, MD PhD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Fé | Valencia | 46009 | Spain |
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| Polymerized TOL of Dermatophagoides pteronyssinus | Biological | Sublingual immunotherapy. Two drops daily during 1 year |
|
| Placebo Comparator | Biological | Sublingual immunotherapy. Two drops daily during 1 year |
|
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
| 1 year |
| Cost-effectiveness | 1 year |
| Dose response prick-test | 1 year |
| Inflammatory markers | 1 year |
| Use of health resources | 1 year |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
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