Trial Outcomes & Findings for Study of MK-0476 in Adult Patients With Acute Asthma (0476-334) (NCT NCT00442338)
NCT ID: NCT00442338
Last Updated: 2022-02-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
91 participants
Primary outcome timeframe
Baseline and 60 minutes after study drug administration
Results posted on
2022-02-02
Participant Flow
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.
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.
Participant milestones
| Measure |
Montelukast 7 mg
Montelukast 7 mg IV Administration
|
Montelukast 14 mg
Montelukast 14 mg Intravenous Administration
|
Aminophylline 250 mg
Aminophylline 250 mg IV drip administration
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
31
|
|
Overall Study
COMPLETED
|
30
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)
Baseline characteristics by cohort
| Measure |
Montelukast 7 mg
n=30 Participants
Montelukast 7 mg IV Administration
|
Montelukast 14 mg
n=30 Participants
Montelukast 14 mg Intravenous Administration
|
Aminophylline 250 mg
n=31 Participants
Aminophylline 250 mg IV drip administration
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56.0 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
56.7 Years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
55.4 Years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
56.0 Years
STANDARD_DEVIATION 13.9 • n=4 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
0 Participants
12.3 • n=5 Participants
|
1 Participants
15.2 • n=7 Participants
|
0 Participants
14.5 • n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Customized
Adults (18-64 years)
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Age, Customized
From 65-84 years
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan
Mild
|
21 Participants
0.29 • n=5 Participants
|
18 Participants
0.33 • n=7 Participants
|
26 Participants
0.53 • n=5 Participants
|
65 Participants
n=4 Participants
|
|
Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan
Moderate
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan
Severe
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Asthma Attack Severity based on Asthma Prevention and Management Guideline 2003, Japan
Serious
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Forced Expiratory Volume in One Second (FEV1)
|
1.35 Liter
STANDARD_DEVIATION 0.29 • n=5 Participants
|
1.18 Liter
STANDARD_DEVIATION 0.33 • n=7 Participants
|
1.43 Liter
STANDARD_DEVIATION 0.53 • n=5 Participants
|
1.32 Liter
STANDARD_DEVIATION 0.41 • n=4 Participants
|
|
Duration of Asthma
|
14.9 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
13.9 Years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
16.7 Years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
15.2 Years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 60 minutes after study drug administrationPopulation: 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.
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.
Outcome measures
| Measure |
Montelukast 7 mg
n=27 Participants
Montelukast 7 mg IV Administration
|
Montelukast 14 mg
n=30 Participants
Montelukast 14 mg IV Administration
|
Aminophylline 250 mg
n=29 Participants
Aminophylline 250 mg IV drip administration
|
|---|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration
|
0.07 Liter
Interval 0.02 to 0.12
|
0.05 Liter
Interval 0.0 to 0.11
|
0.06 Liter
Interval 0.01 to 0.12
|
Adverse Events
Montelukast 7 mg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Montelukast 14 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Aminophylline 250 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Montelukast 7 mg
n=30 participants at risk
Montelukast 7 mg IV Administration
|
Montelukast 14 mg
n=30 participants at risk
Montelukast 14 mg Intravenous Administration
|
Aminophylline 250 mg
n=31 participants at risk
Aminophylline 250 mg IV drip administration
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.7%
2/30 • From Screening through post-trial visit (up to 14 days)
|
0.00%
0/30 • From Screening through post-trial visit (up to 14 days)
|
3.2%
1/31 • From Screening through post-trial visit (up to 14 days)
|
|
General disorders
Pyrexia
|
3.3%
1/30 • From Screening through post-trial visit (up to 14 days)
|
0.00%
0/30 • From Screening through post-trial visit (up to 14 days)
|
0.00%
0/31 • From Screening through post-trial visit (up to 14 days)
|
|
Investigations
White blood cell count increased
|
3.3%
1/30 • From Screening through post-trial visit (up to 14 days)
|
0.00%
0/30 • From Screening through post-trial visit (up to 14 days)
|
0.00%
0/31 • From Screening through post-trial visit (up to 14 days)
|
Other adverse events
| Measure |
Montelukast 7 mg
n=30 participants at risk
Montelukast 7 mg IV Administration
|
Montelukast 14 mg
n=30 participants at risk
Montelukast 14 mg Intravenous Administration
|
Aminophylline 250 mg
n=31 participants at risk
Aminophylline 250 mg IV drip administration
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
2/30 • From Screening through post-trial visit (up to 14 days)
|
0.00%
0/30 • From Screening through post-trial visit (up to 14 days)
|
0.00%
0/31 • From Screening through post-trial visit (up to 14 days)
|
|
Investigations
Glucose urine present
|
6.7%
2/30 • From Screening through post-trial visit (up to 14 days)
|
3.3%
1/30 • From Screening through post-trial visit (up to 14 days)
|
3.2%
1/31 • From Screening through post-trial visit (up to 14 days)
|
|
General disorders
Oedema
|
6.7%
2/30 • From Screening through post-trial visit (up to 14 days)
|
0.00%
0/30 • From Screening through post-trial visit (up to 14 days)
|
0.00%
0/31 • From Screening through post-trial visit (up to 14 days)
|
|
Investigations
White blood cell count increased
|
0.00%
0/30 • From Screening through post-trial visit (up to 14 days)
|
0.00%
0/30 • From Screening through post-trial visit (up to 14 days)
|
6.5%
2/31 • From Screening through post-trial visit (up to 14 days)
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
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