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single center, double-blind, double-dummy, 2-way cross over study in asthmatic children already treated with inhaled corticosteroids
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF 1535 50/6 µg | Experimental |
| |
| beclomethasone dipropionate 100µg + Formoterol fumarate 6µg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg | Drug | beclomethasone dipropionate 50µg + formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lower Leg Growth rate measured by Knemometry | after 2 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour urinary free cortisol/creatinine levels | after 2 weeks of treatment | |
| Changes in pre-dose morning and evening PEF (L/min) | after 2 weeks of treatment |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BørneAstmaKlinikken | Copenhagen | 2100 | Denmark |
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| free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg | Drug | beclomethasone dipropionate 100µg, 1 inhalation b.i.d. for 2 weeks and formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks |
|
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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