Trial Outcomes & Findings for MK0476 Study in Adult Patients With Acute Asthma (0476-322) (NCT NCT00229970)
NCT ID: NCT00229970
Last Updated: 2022-02-02
Results Overview
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
COMPLETED
PHASE3
225 participants
baseline over the first 60 minutes
2022-02-02
Participant Flow
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.
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.
Participant milestones
| Measure |
Montelukast 7 mg
Montelukast 7 mg Intravenous Administration
|
Montelukast 14 mg
Montelukast 14 mg Intravenous Administration
|
Placebo
Placebo Intravenous Administration
|
|---|---|---|---|
|
Overall Study
STARTED
|
78
|
72
|
75
|
|
Overall Study
COMPLETED
|
78
|
72
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MK0476 Study in Adult Patients With Acute Asthma (0476-322)
Baseline characteristics by cohort
| Measure |
Montelukast 7 mg
n=78 Participants
Montelukast 7 mg Intravenous Administration
|
Montelukast 14 mg
n=72 Participants
Montelukast 14 mg Intravenous Administration
|
Placebo
n=75 Participants
Placebo Intravenous Administration
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
41.5 years
STANDARD_DEVIATION 13.1 • n=107 Participants
|
42.3 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
41.4 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
111 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
114 Participants
n=7 Participants
|
|
Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan
Mild
|
54 participants
n=99 Participants
|
44 participants
n=107 Participants
|
56 participants
n=206 Participants
|
154 participants
n=7 Participants
|
|
Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan
Moderate
|
23 participants
n=99 Participants
|
28 participants
n=107 Participants
|
19 participants
n=206 Participants
|
70 participants
n=7 Participants
|
|
Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan
Severe
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan
Serious
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Baseline Forced Expiratory Volume in One Second (FEV1)
|
1.67 Liter
STANDARD_DEVIATION 0.55 • n=99 Participants
|
1.62 Liter
STANDARD_DEVIATION 0.59 • n=107 Participants
|
1.76 Liter
STANDARD_DEVIATION 0.61 • n=206 Participants
|
1.68 Liter
STANDARD_DEVIATION 0.58 • n=7 Participants
|
|
Duration of Asthma
|
18.7 Years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
15.46 Years
STANDARD_DEVIATION 11.6 • n=107 Participants
|
17.7 Years
STANDARD_DEVIATION 11.7 • n=206 Participants
|
17.3 Years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
PRIMARY outcome
Timeframe: baseline over the first 60 minutesPopulation: Last observed value during the 60 minutes treatment period was used in the Full Analysis Set (FAS)
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
Outcome measures
| Measure |
Montelukast 7 mg
n=78 Participants
Montelukast 7 mg Intravenous Administration
|
Montelukast 14 mg
n=72 Participants
Montelukast 14 mg Intravenous Administration
|
Placebo
n=75 Participants
Placebo Intravenous Administration
|
|---|---|---|---|
|
The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)
|
0.09 Liter
Interval 0.04 to 0.15
|
0.17 Liter
Interval 0.12 to 0.23
|
0.01 Liter
Interval -0.05 to 0.06
|
Adverse Events
Montelukast 7 mg
Montelukast 14 mg
Placebo
Serious adverse events
| Measure |
Montelukast 7 mg
Montelukast 7 mg Intravenous Administration
|
Montelukast 14 mg
Montelukast 14 mg Intravenous Administration
|
Placebo
Placebo Intravenous Administration
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/78
|
0.00%
0/72
|
1.3%
1/75
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/78
|
0.00%
0/72
|
1.3%
1/75
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.3%
1/78
|
5.6%
4/72
|
2.7%
2/75
|
|
Gastrointestinal disorders
Gastritis
|
1.3%
1/78
|
0.00%
0/72
|
0.00%
0/75
|
Other adverse events
| Measure |
Montelukast 7 mg
Montelukast 7 mg Intravenous Administration
|
Montelukast 14 mg
Montelukast 14 mg Intravenous Administration
|
Placebo
Placebo Intravenous Administration
|
|---|---|---|---|
|
Investigations
Blood bilirubin increased
|
2.6%
2/77
|
0.00%
0/72
|
0.00%
0/75
|
|
Investigations
Blood potassium decreased
|
2.6%
2/76
|
0.00%
0/72
|
1.4%
1/73
|
|
Investigations
Blood urine present
|
1.3%
1/75
|
2.9%
2/70
|
1.3%
1/75
|
|
Infections and infestations
Bronchitis acute
|
0.00%
0/78
|
2.8%
2/72
|
0.00%
0/75
|
|
General disorders
Chest pain
|
0.00%
0/78
|
0.00%
0/72
|
2.7%
2/75
|
|
Investigations
Glucose urine present
|
5.3%
4/75
|
0.00%
0/70
|
1.3%
1/75
|
|
Nervous system disorders
Headache
|
1.3%
1/78
|
0.00%
0/72
|
2.7%
2/75
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
5/78
|
2.8%
2/72
|
6.7%
5/75
|
|
Investigations
Protein urine present
|
2.7%
2/75
|
0.00%
0/70
|
1.3%
1/75
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
5.1%
4/78
|
1.4%
1/72
|
0.00%
0/75
|
|
Investigations
White blood cell count increased
|
5.2%
4/77
|
5.7%
4/70
|
2.7%
2/75
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER