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| ID | Type | Description | Link |
|---|---|---|---|
| 2004_023 | Other Identifier | Telerx ID Number |
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The purpose of this study is to determine the effect of montelukast, an approved medication, on the lower leg growth rate in children with mild asthma. The primary hypothesis is that the lower leg length (LLL) growth rate for children treated with montelukast compared to placebo will be established.
This is a crossover study that consists of a 2-week placebo run-in period, then a first 3-week treatment period, then a 2-week washout period, and then a second 3-week treatment period. Participants will be randomized to treatment with either montelukast and placebo or budesonide and placebo. The duration of treatment is 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast→Placebo | Experimental | Participants receive one montelukast 5 mg chewable tablet once daily (QD) for 3 weeks. After a 2-week washout period, participants receive one placebo chewable tablet QD for 3 weeks. |
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| Placebo→Montelukast | Experimental | Participants receive one placebo chewable tablet QD for 3 weeks. After a 2-week washout period, participants receive one montelukast 5 mg chewable tablet QD for 3 weeks. |
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| Budesonide→Placebo | Active Comparator | Participants receive budesonide 200 mcg inhalation powder twice daily (BID) for 3 weeks. After a 2-week washout period, participants receive placebo inhalation powder BID for 3 weeks. |
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| Placebo→Budesonide | Active Comparator | Participants receive placebo inhalation powder BID for 3 weeks. After a 2-week washout period, participants receive budesonide 200 mcg inhalation powder BID for 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast chewable tablets | Drug | Montelukast sodium 5 mg chewable tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Short-term lower-leg growth rate (LLGR) | Lower leg length was measured in millimeters (mm) using a knemometer. | Baseline and Week 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17659605 | Background | Pedersen S, Agertoft L, Williams-Herman D, Kuznetsova O, Reiss TF, Knorr B, Dass SB, Wolthers OD. Placebo-controlled study of montelukast and budesonide on short-term growth in prepubertal asthmatic children. Pediatr Pulmonol. 2007 Sep;42(9):838-43. doi: 10.1002/ppul.20666. |
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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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| Budesonide inhaler | Drug | Budesonide 200 mcg inhalation powder |
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| Placebo to montelukast chewable tablets | Drug | Placebo chewable tablets |
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| Placebo to budesonide inhaler | Drug | Placebo inhalation powder |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |