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The purpose of this study is to investigate the efficacy and safety of different doses of sublingual tablets of house dust mite allergen extracts as compared to placebo in adults with house dust mite-associated allergic asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLIT (A) | Experimental | SLIT tablets of HDM allergen extracts, 3 different doses (A) |
|
| SLIT (B) | Experimental | SLIT tablets of HDM allergen extracts, 3 different doses (B) |
|
| SLIT (C) | Experimental | SLIT tablets of HDM allergen extracts, 3 different doses (C) |
|
| Placebo | Placebo Comparator | Placebo matching the SLIT tablets of HDM allergen extracts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLIT tablets of HDM allergen extracts, 3 different doses (A) | Biological | Two sublingual tablets daily for 13 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect on the Asthma control test (ACT) score | Assessment of the effect of one year of treatment of 3 different doses of sublingual immunotherapy tablets of house dust mite (HDM) allergen extracts as compared to placebo on the Asthma Control Test™ (ACT) score, in adults with HDM-associated allergic asthma | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of subjects with treatment-emergent AEs | Measured during 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Immunological parameters (HDM-specific IgE and IgG4 values) | 13 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal Demoly, MD | Montpellier, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Arnaud de Villeneuve | Montpellier | 34295 | France | |||
| NHC, Hôpitaux Universitaires de Strasbourg |
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| SLIT tablets of HDM allergen extracts, 3 different doses (B) | Biological | Two sublingual tablets daily for 13 months |
|
|
| SLIT tablets of HDM allergen extracts, 3 different doses (C) | Biological | Two sublingual tablets daily for 13 months |
|
|
| Placebo matching the SLIT tablets of HDM allergen extracts | Biological | Two sublingual tablets daily for 13 months |
|
|
| Strasbourg |
| 67091 |
| France |
| Universitätsmedizin Berlin - Allergie-Centrum-Charité | Berlin | 10117 | Germany |
| SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi | Lodz | 90-153 | Poland |
| Majorek-Olechowska Bernadetta | Tarnów | 33-100 | Poland |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D000092542 | Dust Mite Allergy |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012221 | Rhinitis, Allergic, Perennial |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D063729 | Sublingual Immunotherapy |
| ID | Term |
|---|---|
| D003888 | Desensitization, Immunologic |
| D007165 | Immunosuppression Therapy |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
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