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To evaluate the effect of a prophylactical therapy with a cough medicine containing ivy leaves dry extract on the frequency of recurrent wheezy bronchitis in toddlers, on the duration of the bronchitis episodes, on the severity and the additional drug demand. A prolonged asymptomatic episode between each wheezy bronchitis due to the therapy is assumed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Syrup | Placebo Comparator | Placebo Syrup 2.5 ml twice daily for 4 weeks | |
| Prospan Syrup | Active Comparator | Prospan Syrup 2.5 ml twice daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prospan Syrup | Drug | 2.5 ml twice daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| the time to event (next bronchitis episode) rate during and after treatment period | three months |
| Measure | Description | Time Frame |
|---|---|---|
| days and percentage of days without bronchitis during and after treatment period | 3 months | |
| days and percentage of days without bronchitis during treatment period | three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Vogelberg, MD PhD | Contact | 0049351458 | 5699 | christian.vogelberg@uniklinikum-dresden.de |
| Name | Affiliation | Role |
|---|---|---|
| Christian Vogelberg, MD PhD | Technische Universität Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin | Recruiting | Dresden | Saxony | 01307 | Germany |
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |