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The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.
Allergen immunotherapy is currently the only one method of cause treatment of the IgE-dependent allergic diseases. Sublingual immunotherapy (SLIT) is the method which allows to give allergens via alternative oral route in patients home. Due to possibility of avoiding injection this therapy offers better relationship with pediatric patient. However efficacy and safety of sublingual immunotherapy are still important issues, especially in asthmatic children. The purpose of the trial is to asses the efficacy and safety of sublingual annual immunotherapy in children with bronchial asthma and/or allergic rhinitis allergic to house dust mites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active group | Active Comparator | Group of children with bronchial asthma and/ or allergic rhinitis 6-18 years old receiving annually house dust mites sublingual allergen extract |
|
| Placebo group | Placebo Comparator | Group of children with bronchial asthma and/or allergic rhinitis 6-18 years old receiving placebo in sublingual applicator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sublingual house dust mites allergen extract | Drug | Staloral 300 IR, Stallergenes, France |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical symptoms of asthma and allergic rhinitis and use of rescue medication | Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of percent of regulatory lymphocytes in peripheral blood | Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT) | |
| assessment of inflammatory markers in exhaled breath condensate and FeNO | Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iwona Stelmach, MD, PhD, Prof | Contact | +48426895972 | alergol@kopernik.lodz.pl |
| Name | Affiliation | Role |
|---|---|---|
| Iwona Stelmach, MD, PhD, Prof | Department of Pediatrics and Allergy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics and Allergy | Recruiting | Lodz | 93-513 | Poland |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| placebo in sublingual applicator |
| Drug |
placebo for Staloral 300 IR, Stallergenes, France |
|
| non-specific bronchial hyperreactivity with methacholine (PC20M), specific conjunctival provocation test | Visit No 2 (before SLIT),VISIT No 4(after 1 year of SLIT), Visit No 6(after 3 years of SLIT) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |