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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_001 |
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This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | montelukast |
|
| 2 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 | Percent change from baseline in FEV1, a measure of airway function, at Week 3 | Baseline and week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period | Percent change from baseline in average daily β-agonist use over the 3-week treatment period | Baseline and Week 3 |
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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 |
|---|---|---|---|
| 19484680 | Background | Papadopoulos NG, Philip G, Giezek H, Watkins M, Smugar SS, Polos PG. The efficacy of montelukast during the allergy season in pediatric patients with persistent asthma and seasonal aeroallergen sensitivity. J Asthma. 2009 May;46(4):413-20. doi: 10.1080/02770900902847727. |
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Patients who had unresolved symptoms and signs of an upper respiratory tract infection between Visits 1 and 2, or had evidence of active, clinically significant sinus infection within 1 week of Visit 1 or between Visits 1 and 2, or failed to meet minimum requirement for daytime asthma symptoms and daily β-agonist use were excluded.
One hundred three sites in US;
Prime Therapy: March 2006 to July 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast 5 mg | Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks. |
| FG001 | Placebo | Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Montelukast 5 mg | Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks. |
| BG001 | Placebo | Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 | Percent change from baseline in FEV1, a measure of airway function, at Week 3 | The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements). | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and week 3 |
|
Adverse events (AEs) were collected during the 6 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the SAE table (203 montelukast & 217 placebo) is the number that received treatment.
Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other categories.
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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 5 mg | Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
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Safety is reported in the literature.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| 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: Placebo | Drug | Placebo. Up to 3 weeks of treatment |
|
| Protocol Violation |
|
| Did not meet eligibility |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Daily β-agonist use | Mean | Standard Deviation | Puffs/Day |
|
| Forced expiratory volume in 1 second (FEV1) | Mean | Standard Deviation | Liters |
|
|
|
| Secondary | Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period | Percent change from baseline in average daily β-agonist use over the 3-week treatment period | The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements). | Posted | Median | Standard Deviation | Percent Change | Baseline and Week 3 |
|
|
|
| 0 |
| 203 |
| 0 |
| 203 |
| EG001 | Placebo | Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks. | 4 | 217 | 0 | 217 |
| Overdose | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |