Asthma
Conditions
Brief summary
This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.
Interventions
DRUGmontelukast sodium
7 mg or 14 mg single injection
DRUGComparator: Placebo
Placebo single injection
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult Patients With Acute Asthma Attacks
Exclusion criteria
* Patient Has Any Known Or Suspected, Acute Or Chronic Cause For Their Pulmonary Symptoms Other Than Asthma (E.G., Copd, Chronic Heart Failure, Etc.) * Patient Has A Smoking History (20 Cigarettes Per Day) Of More Than 15 Years * Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) | baseline over the first 60 minutes | The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor |
Participant flow
Recruitment details
Phase III. Studied period: September 12, 2005 (date study drug was first administered to first patient) to October 23, 2006 (date study drug was last administered to last patient). Study was conducted at 64 clinical sites.
Pre-assignment details
Patients 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.
Participants by arm
| Arm | Count |
|---|---|
| Montelukast 7 mg Montelukast 7 mg Intravenous Administration | 78 |
| Montelukast 14 mg Montelukast 14 mg Intravenous Administration | 72 |
| Placebo Placebo Intravenous Administration | 75 |
| Total | 225 |
Baseline characteristics
| Characteristic | Montelukast 7 mg | Montelukast 14 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 40.5 years STANDARD_DEVIATION 12.5 | 41.5 years STANDARD_DEVIATION 13.1 | 42.3 years STANDARD_DEVIATION 12.5 | 41.4 years STANDARD_DEVIATION 12.7 |
| Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan Mild | 54 participants | 44 participants | 56 participants | 154 participants |
| Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan Moderate | 23 participants | 28 participants | 19 participants | 70 participants |
| Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan Serious | 0 participants | 0 participants | 0 participants | 0 participants |
| Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan Severe | 1 participants | 0 participants | 0 participants | 1 participants |
| Baseline Forced Expiratory Volume in One Second (FEV1) | 1.67 Liter STANDARD_DEVIATION 0.55 | 1.62 Liter STANDARD_DEVIATION 0.59 | 1.76 Liter STANDARD_DEVIATION 0.61 | 1.68 Liter STANDARD_DEVIATION 0.58 |
| Duration of Asthma | 18.7 Years STANDARD_DEVIATION 11.5 | 15.46 Years STANDARD_DEVIATION 11.6 | 17.7 Years STANDARD_DEVIATION 11.7 | 17.3 Years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 41 Participants | 34 Participants | 36 Participants | 111 Participants |
| Sex: Female, Male Male | 37 Participants | 38 Participants | 39 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 23 / — | 11 / — | 13 / — |
| serious Total, serious adverse events | 2 / — | 4 / — | 4 / — |
Outcome results
Primary
The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)
The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor
Time frame: baseline over the first 60 minutes
Population: Last observed value during the 60 minutes treatment period was used in the Full Analysis Set (FAS)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Montelukast 7 mg | The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) | 0.09 Liter |
| Montelukast 14 mg | The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) | 0.17 Liter |
| Placebo | The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) | 0.01 Liter |
p-value: 0.02295% CI: [0.01, 0.16]ANCOVA
p-value: <0.00195% CI: [0.09, 0.24]ANCOVA