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| ID | Type | Description | Link |
|---|---|---|---|
| IND 103263 | Other Identifier | FDA |
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The primary rationale for this study is to evaluate the effect of once daily montelukast on duration of acute illness in infants with first-time bronchiolitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| montelukast sodium | Experimental | 4mg granules PO QD for 14 days |
|
| Placebo | Placebo Comparator | Sucrose granules PO QD for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | 4mg granules daily for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Cough | up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Gorelick, MD, MSCE | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast | 4mg granules montelukast sodium: 4mg granules daily for 14 days |
| FG001 | Placebo | sucrose: table sugar as placebo daily for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Montelukast | 4mg granules montelukast sodium: 4mg granules daily for 14 days |
| BG001 | Sucrose | sucrose: table sugar as placebo daily for 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Cough | Posted | Median | Inter-Quartile Range | days | up to 4 weeks |
|
|
4 weeks
Assessment was made via weekly follow up telephone interviews
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Montelukast | 4mg granules montelukast sodium: 4mg granules daily for 14 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank Petruzella | Richmond Emergency Physicians Inc | 773 447-2489 | fpetruzella@gmail.com |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| sucrose | Other | table sugar as placebo daily for 14 days |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| 0 |
| 68 |
| 7 |
| 68 |
| EG001 | Placebo | sucrose: table sugar as placebo daily for 14 days | 0 | 73 | 5 | 73 |
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
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| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D000073893 |
| Sugars |