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| ID | Type | Description | Link |
|---|---|---|---|
| 20060504(142/06) |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Viral upper respiratory tract infection (URI) is one of the most common diseases among toddlers and pre-school children.Complete and effective prevention measures for URI are currently unavailable.
Montelukast (Singulair ) is a selective leukotriene-receptor antagonist that inhibits the cysteinyl leukotriene 1 receptor. It is well tolerated and safe even in young children. Montelukast is an effective treatment for asthma (and allergic rhinitis from 1 year of age. Infections with viruses causing URI such as Influenza A, Rhinovirus and respiratory syncitial virus increases leukotriens levels in nasal secretions. Therefore, one may postulate that leukotriens inhibitors may reduce symptoms during URI. However the effect of montelukast as a treatment for non-specific cough was not properly studied and there are no studies on the effect of montelukast as prevention for URI.
Hypothesis: Prophylactic treatment with Montelukast will reduce the incidence and severity of upper respiratory infection in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muntelukast | Drug | Tablets or granules; 4 mg once a day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number and duration of URI episodes | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of URI episodes,number of days with fever,antibiotic and antipyretic usage, unscheduled visits to physicians office, child's absence from day care or kindergarten, parental absence from work, hospital admissions and adverse reaction of the drug. | 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mati Berkovitch, MD | Contact | 972 8 9779152 | mberkovitch@asaf.health.gov.il | |
| Eran Kozer, MD | Contact | 972 8 9778131 | erank@asaf.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Mati Berkovitch, MD | Assaf-Harofeh Medical Center | Principal Investigator |
| Eran Kozer, MD | Assaf-Harofeh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kupat Cholim Clalit | Recruiting | Lod | Israel |
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| Placebo | Drug | Look alike tablets or granules 1 per day for 12 weeks |
|
| Kupat Cholim Clalit | Recruiting | Ramla | Israel |
|
| Assaf Harofeh | Recruiting | Ẕerifin | 70300 | Israel |
|
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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