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This is a single centre, double-blind, double-dummy, randomised, single-centre, 2-way cross-over study in asthmatic children already treated with inhaled corticosteroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF 1535 50/6µg | Experimental |
| |
| beclomethasone dipropionate 50µg + formoterol fumarate 6µg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF 1535 50/6µg | Drug | fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lower leg growth rate measured by knemometry | after a 2 week treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour urinary free cortisol/creatinine levels | after a 2 week treatment period | |
| Changes in pre-dose morning and evening PEF (L/min) | pre and after a 2 week treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Bisgaard, MD | BørneAstmaKlinikken | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BørneAstmaKlinikken | Copenhagen | 2100 | Denmark |
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| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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| beclomethasone dipropionate 50µg + formoterol fumarate 6µg | Drug | free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg |
|
| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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