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| ID | Type | Description | Link |
|---|---|---|---|
| MK0524-008 | |||
| 2007_614 |
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The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo in patients with chronic asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Treatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast |
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| 2 | Experimental | Treatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: MK0524 + placebo | Drug | Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1) | Last 2 weeks of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the benefits of MK0524 as compared with placebo on the key secondary endpoints (Daytime & Nighttime Asthma Symptoms scores | Last 2 weeks of each treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19748656 | Derived | Philip G, van Adelsberg J, Loeys T, Liu N, Wong P, Lai E, Dass SB, Reiss TF. Clinical studies of the DP1 antagonist laropiprant in asthma and allergic rhinitis. J Allergy Clin Immunol. 2009 Nov;124(5):942-8.e1-9. doi: 10.1016/j.jaci.2009.07.006. Epub 2009 Sep 12. |
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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 |
|---|---|
| C093875 | montelukast |
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| Comparator: MK0524 + montelukast | Drug | Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks |
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| Comparator: placebo + montelukast | Drug | Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks |
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| Comparator: Placebo | Drug | During the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks. |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |