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| ID | Type | Description | Link |
|---|---|---|---|
| MK-0476-334 | |||
| 2007_007 |
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The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast 7 mg | Experimental | Montelukast 7 mg IV administration |
|
| Montelukast 14 mg | Experimental | Montelukast 14 mg IV administration |
|
| Aminophylline 250 mg | Active Comparator | Aminophylline 250 mg IV drip administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast sodium | Drug | Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration | The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period. | Baseline and 60 minutes after study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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Participants with acute exacerbation of bronchial asthma received standard treatments of inhaled β-agonist or oxygen inhalation to treat the acute exacerbations during the 60 minutes in the screening period before the study randomization.
Phase III.
Studied period: March 12, 2007 (date study drug was first administered to first participant) to August 1, 2007 (date study drug was last administered to last participant). Study was conducted at 31 clinical sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast 7 mg | Montelukast 7 mg IV Administration |
| FG001 | Montelukast 14 mg | Montelukast 14 mg Intravenous Administration |
| FG002 | Aminophylline 250 mg | Aminophylline 250 mg IV drip administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Montelukast 7 mg | Montelukast 7 mg IV Administration |
| BG001 | Montelukast 14 mg | Montelukast 14 mg Intravenous Administration |
| 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 | Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration | The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period. | Per Protocol Set (PPS): subset of participants who comply with the protocol sufficiently to ensure that these data will likely exhibit effects of treatment, according to the underlying scientific model. Aminophylline 250 mg - 1 participant with no FEV1 data at 60 minutes was excluded from the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Liter | Baseline and 60 minutes after study drug administration |
|
From Screening through post-trial visit (up to 14 days)
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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 7 mg | Montelukast 7 mg IV Administration |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| 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 |
| D013806 | Theophylline |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| montelukast sodium | Drug | Montelukast 14 mg single injection (IV bolus administration) over 5 minutes |
|
|
| aminophylline hydrate | Drug | Aminophylline 250 mg IV drip infusion over 60 minutes |
|
|
| BG002 | Aminophylline 250 mg | Aminophylline 250 mg IV drip administration |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan | Mild (Peak Expiratory Flow: 70%-80%), Moderate (Peak Expiratory Flow: 50%-70%), Severe (Peak Expiratory Flow: <=50%) or Serious (Peak Expiratory Flow: incapable measurement, cyanosis, head trip, disturbed consciousness, incontinence or asphyxia) | Number | Participants |
|
| Baseline Forced Expiratory Volume in One Second (FEV1) | Mean | Standard Deviation | Liter |
|
| Duration of Asthma | Mean | Standard Deviation | Years |
|
| OG001 | Montelukast 14 mg | Montelukast 14 mg IV Administration |
| OG002 | Aminophylline 250 mg | Aminophylline 250 mg IV drip administration |
|
|
|
| 3 |
| 30 |
| 5 |
| 30 |
| EG001 | Montelukast 14 mg | Montelukast 14 mg Intravenous Administration | 0 | 30 | 1 | 30 |
| EG002 | Aminophylline 250 mg | Aminophylline 250 mg IV drip administration | 1 | 31 | 3 | 31 |
| Pyrexia | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 9.1 | 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 |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |