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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018621-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Ergomed | INDUSTRY |
| ACM Pivotal Global Central Laboratory | INDUSTRY |
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The purpose of this trial is to investigate if treatment with house dust mite allergen immunotherapy tablet can reduce the risk of asthma exacerbation in subjects with house dust mite induced asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| ALK HDM AIT 6 DU | Experimental |
| |
| ALK HDM AIT 12 DU | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALK HDM AIT Placebo | Drug | Oral lyophilisate, Placebo, to be administered sublingually once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first moderate or severe asthma exacerbation after ICS reduction | Measured during the last 6 months of the trial |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in changes in immunological parameters (IgE, IgG4) | Measured at the end of the trial | |
| Time to first severe asthma exacerbation after ICS reduction | Measured during the last 6 months of the trial |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Virchow, Prof.Dr.med. | Dept. fof Pneumology, University Clinic Rostock, Ernst-Heydemann-Str. 6, 18057 Rostock, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Rostock, Abteilung für Pneumologie Zentrum für Innere Medizin, Ernst Heydemann Strasse 6 | Rostock | 18057 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38160049 | Derived | Hoof I, Bonnelykke K, Stranzl T, Brand S, Li X, Shamji MH, Meyers DA, Bateman ED, Bleecker E, Andersen PS. Genetic and T2 biomarkers linked to the efficacy of HDM sublingual immunotherapy in asthma. Thorax. 2024 Mar 15;79(4):332-339. doi: 10.1136/thorax-2023-220707. | |
| 32926419 | Derived | Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ALK HDM AIT 6 DU | Drug | Oral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months. |
|
| ALK HDM AIT 12 DU | Drug | Oral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months. |
|
| Frequency of asthma exacerbations following ICS reduction | Measured during the last 6 months of the trial |
| The average overall symptom score. | Measured during the last 6 months of the trial |
| Symptom free days | Measured during the last 6 months of the trial |
| Number and percentage of subjects with treatment emergent AEs | At end of trial |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |