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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010108-27 | EudraCT Number |
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The purpose of this study is to assess the effect of one of five possible study medications used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years with persistent asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MF/F MDI 50/10 mcg BID | Experimental |
| |
| MF/F MDI 100/10 mcg BID | Experimental |
| |
| MF/F MDI 200/10 mcg BID | Experimental |
| |
| BDP HFA 160 mcg BID | Active Comparator |
| |
| Montelukast 5 mg QD (4 mg QD for 5-year-olds) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MF/F Metered Dose Inhaler (MDI) 25/5 mcg | Drug | MF/F MDI 25/5 mcg, 2 inhalations twice a day (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Plasma Cortisol Area Under the Curve (AUC) 0-24 hrs | Baseline (Day 1) and Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Plasma Cortisol Trough Concentration (Ctrough) | Baseline (Day 1) and Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| MF/F MDI 50/5 mcg | Drug | MF/F MDI 50/5 mcg, 2 inhalations BID |
|
|
| MF/F MDI 100/5 mcg | Drug | MF/F MDI 100/5 mcg, 2 inhalations BID |
|
|
| BDP hydrofluoroalkane (HFA) 80 mcg | Drug | BDP HFA 80 mcg, 2 inhalations BID |
|
|
| Montelukast tablets 5 mg (4 mg for children 5 years of age) | Drug | Montelukast chewable tablets 5 mg once daily (QD) for children 6-11 years of age OR Montelukast chewable tablets 4 mg QD for children 5 years of age |
|
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| Rescue medication: short-acting beta-2 agonist (SABA) MDI | Drug | albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed |
|
| Rescue medication: Prednisone/Prednisolone | Drug | Prednisone/Prednisolone for rescue medication, taken as directed |
|
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068758 | Mometasone Furoate, Formoterol Fumarate Drug Combination |
| D001507 | Beclomethasone |
| C093875 | montelukast |
| D000375 | Aging |
| C046122 | 3-(2-(4-azidobenzamidino)ethyl)-5-hydroxyindole |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D000068656 | Mometasone Furoate |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D011246 | Pregnadienetriols |
| D013258 | Steroids, Chlorinated |
| D048788 | Growth and Development |
| D010829 | Physiological Phenomena |
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