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This is an open-label, non-controlled, non-randomised, prospective safety study in patients with rhinitis or allergic rhinoconjunctivitis, with controlled asthma, and clinically relevant sensitisation to dust mites from the Pyroglyphidae and Glycyphagidae families.
The objective is to evaluate the safety and tolerability of the administration of two allergen extracts of dust mite mixtures at 200 DPP/ml (DP/MG/14-1 Dermatophagoides pteronyssinus / Blomia tropicalis and DP/MG/14-2 Dermatophagoides pteronyssinus / Lepidoglyphus destructor) using a rush build-up phase in patients with allergic rhinitis or rhinoconjunctivitis, with controlled asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DP/MG/14-1 | Experimental | DP/MG/14-1: Depigmented modified allergen extract of D. pteronyssinus 50% / Depigmented, glutaraldehyde-polymerised B. tropicalis 50% (200DPP/mL) The administration regimen will consist of a rush build-up régimen and a follow up period |
|
| DP/MG/14-2 | Experimental | DP/MG/14-2: Depigmented modified allergen extract of D. pteronyssinus 50% / Depigmented, glutaraldehyde-polymerised L.destructor 50% (200DPP/mL) The administration regimen will consist of a rush build-up régimen and a follow up period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DP/MG/14-1 | Biological | The administration regimen will consist of a rush build-up régimen and a follow up period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjects (%) suffering from immediate or delayed systemic grade 2 reactions | Subjects (%) suffering from immediate or delayed systemic grade 2 reactions, according to EACCI 2006 classification, along the study | Safety: local and systemic adverse reactions (EAACI classification) within 24 and 48 hours after the treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Sanchez | Laboratorios Leti, S.L.U | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Conxo | Santiago de Compostela | A Coruña | 15706 | Spain | ||
| Hosp Ntra Sra de la Candelaria |
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| DP/MG/14-2 | Biological | The administration regimen will consist of a rush build-up régimen and a follow up period |
|
| Santa Cruz de Tenerife |
| Tenerife |
| 38010 |
| Spain |
| Hospital Lucus-Augusti | Lugo | 27003 | Spain |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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