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The goal of treatment with AICS is weaning from oral corticosteroids, i.e. a reduction of the oral corticosteroid dose. An anticipated treatment benefit of AICS is a reduction of oral corticosteroid dose and stability/improvement of clinical parameters related to asthma in the targeted subject population. Ultimately, the goal is to free subjects with severe asthma from the burden of chronic oral steroid therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide high dose via AKITA (1mg/2ml) | Experimental |
| |
| Budesonide low dose via AKITA (0.5mg/2ml) | Experimental |
| |
| Budesonide high dose via conventional nebulizer (1mg/2ml) | Active Comparator |
| |
| Placebo via AKITA | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug |
| ||
| Budesonide |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Kardos, MD | Peter Kardos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | 10717 | Germany | ||||
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| Label | URL |
|---|---|
| Homepage of the trial sponsor | View source |
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|
| Budesonide | Drug |
|
| Bonn |
| 53119 |
| Germany |
| Bonn | 53123 | Germany |
| Darmstadt | 64287 | Germany |
| Peter, Kardos, MD | Frankfurt | 60318 | Germany |
| Marburg | 35037 | Germany |
| München | 80331 | Germany |
| Rodgau-Dudenhofen | 63110 | Germany |
| Rüdersdorf | 15562 | Germany |
| Schwetzingen | 68723 | Germany |
| Katowice | 40-752 | Poland |
| Krakow | 31-159 | Poland |
| Lódz | 92-215 | Poland |
| Lublin | 20-954 | Poland |
| Poznán | 60-214 | Poland |
| Skierniewice | 96-100 | Poland |
| Warsaw | 02-097 | Poland |
| Wroclaw | 50-239 | Poland |
| Dnipropetrovsk | 49074 | Ukraine |
| Donetsk | 83099 | Ukraine |
| Ivano-Frankivsk | 76018 | Ukraine |
| Kharkiv | 61124 | Ukraine |
| Kyiv | 03680 | Ukraine |
| Vinnytsia | 21029 | Ukraine |
| ID | Term |
|---|---|
| D001249 | Asthma |
| 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 |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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