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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_583 | Other Identifier | Telerx ID Number |
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Based on input from regulatory agencies, it is not necessary to conduct this study. An ongoing study was sufficient for regulatory purposes.
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A study to determine the effects of montelukast (MK-0476) on pediatric participants with chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of treatment, daily administration of montelukast will be safe and well tolerated in children aged 6 months to 5 years with chronic asthma.
This trial was stopped at a time before any participants had actually entered the trial. Based on input from regulatory agencies, it is not necessary to conduct this study; a separate ongoing study was sufficient for regulatory purposes.
This study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast | Experimental | Participants receive montelukast 4 mg oral granules (OG) or 4 mg chewable tablets (CT) once daily (QD) for 24 weeks and placebo to fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks. Participants aged >6 months to <2 years receive montelukast 4 mg packet of OG QD for 24 weeks. Participants aged >2 years to <64 months receive montelukast 4 mg CT QD for 24 weeks. |
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| Fluticasone | Active Comparator | Participants receive fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks and placebo to montelukast 4 mg QD for 24 weeks. Participants aged >6 months to <2 years receive placebo packet of OG QD for 24 weeks. Participants aged >2 years to <64 months receive placebo CT QD for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast sodium | Drug | Montelukast 4 mg OG or montelukast 4 mg CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of days without asthma | A day without asthma is defined as a day with all of the following: no daytime symptoms, no nighttime cough, no β-agonist use, and no asthma attack (defined as a visit to a doctor, urgent care clinic, emergency room, or hospital for asthma [other than a scheduled visit to a doctor], or treatment with systemic corticosteroid during the previous 24 hours). | 24 weeks |
| Number of participants who experience at least one adverse event (AE) | Up to 26 weeks | |
| Number of participants who discontinue study drug due to an AE | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of days without daytime symptoms | 24 weeks | |
| Percentage of days without nighttime cough | 24 weeks | |
| Percentage of days without β-agonist use |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants without asthma attacks | 24 weeks | |
| Percentage of participants without corticosteroid rescues | 24 weeks | |
| Caregiver global evaluation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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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 |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo to montelukast | Drug | Placebo OG or CT |
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| Fluticasone propionate | Drug | Fluticasone 50 mcg inhalation aerosol metered dose inhaler |
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| Placebo to fluticasone | Drug | Placebo inhalation aerosol metered dose inhaler |
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| 24 weeks |
| Week 24 |
| Physician global evaluation | Week 24 |
| Percentage of days without individual daytime asthma symptoms (cough, wheeze, trouble breathing, and activity limitation) | 24 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |