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The trial aims to record possible effects of a supplementary treatment with ivy leaves dry extract on different lung function parameter, on bronchial hyperreactivity, on individual markers of asthmatic inflammation and on the clinical symptom profile. The hypothesis is, that the additional therapy might improve these parameters and might help to optimize asthma therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ivy leave | Active Comparator | active therapy arm with Ivy leave 5 ml twice daily p.o. for four weeks |
|
| Placebo | Placebo Comparator | Ivy leave placebo 5 ml twice daily p.o. for four weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ivy leaves dry extract | Drug | 5 ml twice daily po |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| MEF75-25 before bronchodilation - relative change | MEF75-25 will be measured at every time point of the study and relative changes will be followed | every 4 weeks |
| FEV1 before bronchodilation - relative change | FEV1 before bronchodilation will be measured at every study visit and changes will be documented | every 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MEF75-25 before bronchodilation - absolute change | every 4 weeks | |
| FEV1 before bronchodilation - absolute change | FEV1 before bronchodilation will be measured every visit and changes documented |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Vogelberg, MD PhD | Contact | 0049 351 458 2073 | christian.vogelberg@uniklinikum-dresden.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Carl Gustav Carus, Kinderklinik | Recruiting | Dresden | Saxony | 01307 | Germany |
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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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| ID | Term |
|---|---|
| C000608183 | EA 575 extract |
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| Drug |
5 ml per os twice daily |
|
| every 4 weeks |
| Emergency treatment (beta agonist demand) | Emergency treatment (beta agonist demand)will be documented daily at home and checked at every study visit | daily |
| Number of days with asthma symptoms | Number of days with asthma symptoms will be documented daily and checked at every study visit. | daily |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |