Trial Outcomes & Findings for The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388) (NCT NCT00739297)
NCT ID: NCT00739297
Last Updated: 2024-05-09
Results Overview
FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
68 participants
Primary outcome timeframe
0 (=baseline) to 4 hours after treatment with montelukast
Results posted on
2024-05-09
Participant Flow
Patients were recruited from 6 centers in the United States between July and December 2008.
117 participants were screened; 49 were excluded. Randomized patients met the following criteria during the prestudy period: FEV1 (Forced expiratory volume in one second) 50-85% predicted while withholding short-acting beta agonist (SABA) and reversibility of airway obstruction \>12% following SABA at Visits 1 and 2.
Participant milestones
| Measure |
Placebo
Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
25 mcg Montelukast
Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
100 mcg Montelukast
Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
250 mcg Montelukast
Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
500 mcg Montelukast
Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
1000 mcg Montelukast
Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
Total
Consistent with the "incomplete-block" design of this study, 6 treatments (placebo and 5 active-dose levels) were administered during only 4 treatment periods. In other words, in this 4-period crossover design, no patient received all 6 treatments and thus some treatments were not
received by all of the patients. Therefore, the TOTAL number of participants across ALL the dose levels provides the best metric to follow the consistency of patient flow from one treatment period to the next treatment period.
|
|---|---|---|---|---|---|---|---|
|
First Intervention (Visit 3 to Visit 4)
STARTED
|
17
|
11
|
6
|
19
|
6
|
9
|
68
|
|
First Intervention (Visit 3 to Visit 4)
COMPLETED
|
17
|
11
|
6
|
19
|
6
|
9
|
68
|
|
First Intervention (Visit 3 to Visit 4)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Washout Period of 4-7 Days
STARTED
|
17
|
11
|
6
|
19
|
6
|
9
|
68
|
|
First Washout Period of 4-7 Days
COMPLETED
|
17
|
11
|
6
|
17
|
6
|
9
|
66
|
|
First Washout Period of 4-7 Days
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
0
|
2
|
|
Second Intervention (Visit 5 to Visit 6)
STARTED
|
18
|
8
|
10
|
14
|
6
|
10
|
66
|
|
Second Intervention (Visit 5 to Visit 6)
COMPLETED
|
18
|
8
|
10
|
14
|
6
|
10
|
66
|
|
Second Intervention (Visit 5 to Visit 6)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Washout Period of 4-7 Days
STARTED
|
18
|
8
|
10
|
14
|
6
|
10
|
66
|
|
Second Washout Period of 4-7 Days
COMPLETED
|
18
|
8
|
10
|
14
|
6
|
10
|
66
|
|
Second Washout Period of 4-7 Days
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (Visit 7 to Visit 8)
STARTED
|
16
|
12
|
6
|
18
|
6
|
8
|
66
|
|
Third Intervention (Visit 7 to Visit 8)
COMPLETED
|
16
|
12
|
6
|
18
|
6
|
8
|
66
|
|
Third Intervention (Visit 7 to Visit 8)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Washout Period of 4-7 Days
STARTED
|
16
|
12
|
6
|
18
|
6
|
8
|
66
|
|
Third Washout Period of 4-7 Days
COMPLETED
|
16
|
12
|
6
|
18
|
6
|
8
|
66
|
|
Third Washout Period of 4-7 Days
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Fourth Intervention(Visit 9 to Visit 10)
STARTED
|
16
|
11
|
8
|
15
|
7
|
9
|
66
|
|
Fourth Intervention(Visit 9 to Visit 10)
COMPLETED
|
16
|
11
|
8
|
15
|
7
|
8
|
65
|
|
Fourth Intervention(Visit 9 to Visit 10)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
25 mcg Montelukast
Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
100 mcg Montelukast
Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
250 mcg Montelukast
Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
500 mcg Montelukast
Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
1000 mcg Montelukast
Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
Total
Consistent with the "incomplete-block" design of this study, 6 treatments (placebo and 5 active-dose levels) were administered during only 4 treatment periods. In other words, in this 4-period crossover design, no patient received all 6 treatments and thus some treatments were not
received by all of the patients. Therefore, the TOTAL number of participants across ALL the dose levels provides the best metric to follow the consistency of patient flow from one treatment period to the next treatment period.
|
|---|---|---|---|---|---|---|---|
|
First Washout Period of 4-7 Days
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
0
|
2
|
|
Fourth Intervention(Visit 9 to Visit 10)
Patient unable to attend last visit
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)
Baseline characteristics by cohort
| Measure |
All Participants
n=68 Participants
Combined participants from all arms.
|
|---|---|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
FEV1 (Forced Expiratory Volume in One Second)
|
2.44 L (Liter)
STANDARD_DEVIATION 0.63 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (=baseline) to 4 hours after treatment with montelukastPopulation: Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.
FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.
Outcome measures
| Measure |
Placebo
n=67 Participants
Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
25 mcg Montelukast
n=42 Participants
Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
100 mcg Montelukast
n=30 Participants
Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
250 mcg Montelukast
n=66 Participants
Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
500 mcg Montelukast
n=25 Participants
Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
1000 mcg Montelukast
n=36 Participants
Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in FEV1 Over 4 Hours
|
0.03 L (Liter)
Interval -0.03 to 0.1
|
0.07 L (Liter)
Interval 0.0 to 0.14
|
0.13 L (Liter)
Interval 0.06 to 0.2
|
0.10 L (Liter)
Interval 0.04 to 0.16
|
0.09 L (Liter)
Interval 0.01 to 0.16
|
0.12 L (Liter)
Interval 0.05 to 0.19
|
SECONDARY outcome
Timeframe: 4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukastPopulation: Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (albuterol or matching placebo) 4 hours after treatment with montelukast at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.
FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.
Outcome measures
| Measure |
Placebo
n=26 Participants
Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
25 mcg Montelukast
n=41 Participants
Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
100 mcg Montelukast
Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
250 mcg Montelukast
Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
500 mcg Montelukast
Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
1000 mcg Montelukast
Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration
|
0.34 L
Interval 0.22 to 0.45
|
0.15 L
Interval 0.06 to 0.24
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 (baseline) and 8 hours after treatment with montelukastPopulation: Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.
Average change from baseline in FEV1 at 8 hours after single dose montelukast administration.
Outcome measures
| Measure |
Placebo
n=67 Participants
Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
25 mcg Montelukast
n=42 Participants
Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
100 mcg Montelukast
n=30 Participants
Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
250 mcg Montelukast
n=66 Participants
Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
500 mcg Montelukast
n=24 Participants
Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
1000 mcg Montelukast
n=35 Participants
Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in FEV1 at 8 Hours After Treatment With Montelukast
|
0.06 L
Interval -0.02 to 0.14
|
0.11 L
Interval 0.03 to 0.2
|
0.13 L
Interval 0.04 to 0.23
|
0.11 L
Interval 0.03 to 0.19
|
0.12 L
Interval 0.02 to 0.22
|
0.14 L
Interval 0.05 to 0.23
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 (baseline) and 24 hours after treatment with montelukastPopulation: Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.
Average change from baseline in FEV1 at 24 hours after single dose montelukast administration.
Outcome measures
| Measure |
Placebo
n=67 Participants
Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
25 mcg Montelukast
n=42 Participants
Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
100 mcg Montelukast
n=29 Participants
Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
250 mcg Montelukast
n=66 Participants
Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
500 mcg Montelukast
n=25 Participants
Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
1000 mcg Montelukast
n=36 Participants
Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
|---|---|---|---|---|---|---|
|
Change From Baseline in FEV1 at 24 Hours After Treatment With Montelukast
|
0.02 L
Interval -0.06 to 0.09
|
0.05 L
Interval -0.03 to 0.13
|
0.10 L
Interval 0.01 to 0.19
|
0.06 L
Interval -0.01 to 0.13
|
0.08 L
Interval -0.01 to 0.18
|
0.09 L
Interval 0.01 to 0.18
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
25 mcg Montelukast
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
100 mcg Montelukast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
250 mcg Montelukast
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
500 mcg Montelukast
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1000 mcg Montelukast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=67 participants at risk
Patients are randomized to receive placebo for montelukast on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions, either albuterol or placebo for albuterol is administered 4 hours after placebo for montelukast. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
25 mcg Montelukast
n=41 participants at risk
Patients are randomized to receive montelukast 25 mcg (microgram) on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 25 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
100 mcg Montelukast
n=30 participants at risk
Patients are randomized to receive montelukast 100 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 100 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
250 mcg Montelukast
n=66 participants at risk
Patients are randomized to receive montelukast 250 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 250 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
500 mcg Montelukast
n=25 participants at risk
Patients are randomized to receive montelukast 500 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 500 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
1000 mcg Montelukast
n=36 participants at risk
Patients are randomized to receive montelukast 1000 mcg on either Intervention I (Visit 3), Intervention II (Visit 5), Intervention III (Visit 7) or Intervention IV (Visit 9). At all interventions either albuterol or placebo for albuterol is administered 4 hours after montelukast 1000 mcg. During the washout periods separating the intervention periods, patients received no study treatment (i.e., patients did not receive montelukast or placebo treatment).
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/67
|
0.00%
0/41
|
0.00%
0/30
|
1.5%
1/66
|
0.00%
0/25
|
0.00%
0/36
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/67
|
0.00%
0/41
|
0.00%
0/30
|
0.00%
0/66
|
4.0%
1/25
|
0.00%
0/36
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
1/67
|
0.00%
0/41
|
0.00%
0/30
|
1.5%
1/66
|
0.00%
0/25
|
0.00%
0/36
|
|
Infections and infestations
Viral infection
|
1.5%
1/67
|
0.00%
0/41
|
0.00%
0/30
|
0.00%
0/66
|
0.00%
0/25
|
0.00%
0/36
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.5%
1/67
|
0.00%
0/41
|
0.00%
0/30
|
0.00%
0/66
|
0.00%
0/25
|
0.00%
0/36
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/67
|
0.00%
0/41
|
0.00%
0/30
|
0.00%
0/66
|
4.0%
1/25
|
0.00%
0/36
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/67
|
0.00%
0/41
|
0.00%
0/30
|
0.00%
0/66
|
4.0%
1/25
|
0.00%
0/36
|
|
Nervous system disorders
Headache
|
0.00%
0/67
|
0.00%
0/41
|
0.00%
0/30
|
1.5%
1/66
|
0.00%
0/25
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.5%
1/67
|
0.00%
0/41
|
0.00%
0/30
|
0.00%
0/66
|
0.00%
0/25
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/67
|
0.00%
0/41
|
0.00%
0/30
|
0.00%
0/66
|
0.00%
0/25
|
0.00%
0/36
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/67
|
2.4%
1/41
|
0.00%
0/30
|
0.00%
0/66
|
0.00%
0/25
|
0.00%
0/36
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/67
|
0.00%
0/41
|
0.00%
0/30
|
0.00%
0/66
|
4.0%
1/25
|
0.00%
0/36
|
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