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| ID | Type | Description | Link |
|---|---|---|---|
| EudractCT-nr 2006-003013-41 |
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The purpose of this study is to assess if treatment with budesonide 200 microgram per day affects short- or long term growth in children with asthma
When children with asthma are treated with inhaled corticosteroids there is a risk of systemic adverse events such as growth suppression. It has been reported that treatment with budesonide 200 microgram per day does not affect short term growth in children with asthma. The aim of the present study is to assess if an unaffected short term growth means that also long term growth will be unaffected.
Short and long term growth in asthmatic children treated with budesonide will be compared with the growth in asthmatic children treated with montelukast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Budesonide |
|
| 2 | Active Comparator | Montelukast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | 200µg daily |
| |
| Montelukast |
| Measure | Description | Time Frame |
|---|---|---|
| Lower leg growth rate | one year | |
| Height | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ole D Wolthers | Children's Clinic Randers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Clinic Randers | Randers | 8900 | Denmark |
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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 |
|---|---|
| D019819 | Budesonide |
| C093875 | montelukast |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
5 mg daily |
|
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |