Trial Outcomes & Findings for Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911) (NCT NCT00127166)
NCT ID: NCT00127166
Last Updated: 2024-05-10
Results Overview
The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
154 participants
Primary outcome timeframe
4 weeks (Weeks 0 to 4 or Weeks 6 to 10)
Results posted on
2024-05-10
Participant Flow
Multicenter Study (30 Ex-US sites) Study Initiation Date: December 22, 2005 Study Completion Date: November 14, 2008
For randomization, patients fulfilled the following criteria: 1. Forced Expiratory Volume in one second (FEV1) ≥70% predicted while withholding beta (β)-agonist for at least 6 hours 2. Exercise-induced bronchoconstriction (EIB) showing FEV1 ≥15% reduction from baseline while on inhaled corticosteroids demonstrated twice during the run-in period.
Participant milestones
| Measure |
Montelukast / Salmeterol
Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
|
Salmeterol / Montelukast
Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
|
|---|---|---|
|
Period I
STARTED
|
78
|
76
|
|
Period I
COMPLETED
|
75
|
74
|
|
Period I
NOT COMPLETED
|
3
|
2
|
|
Washout Period
STARTED
|
75
|
74
|
|
Washout Period
COMPLETED
|
75
|
73
|
|
Washout Period
NOT COMPLETED
|
0
|
1
|
|
Period II
STARTED
|
75
|
73
|
|
Period II
COMPLETED
|
72
|
73
|
|
Period II
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Montelukast / Salmeterol
Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
|
Salmeterol / Montelukast
Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
|
|---|---|---|
|
Period I
Protocol Violation
|
0
|
2
|
|
Period I
Withdrawal by Subject
|
2
|
0
|
|
Period I
Patient did not meet inclusion criteria
|
1
|
0
|
|
Washout Period
Patient did not meet inclusion criteria
|
0
|
1
|
|
Period II
Withdrawal by Subject
|
2
|
0
|
|
Period II
Patient did not perform Visit 6 exercise
|
1
|
0
|
Baseline Characteristics
Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)
Baseline characteristics by cohort
| Measure |
Montelukast / Salmeterol
n=78 Participants
Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
|
Salmeterol / Montelukast
n=76 Participants
Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.2 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
9.8 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
10.0 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
38 participants
n=5 Participants
|
41 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Area Under the Curve from 0 to 20 minutes (AUC0-20)
|
320.08 Percent times Minutes
STANDARD_DEVIATION 208.62 • n=5 Participants
|
317.74 Percent times Minutes
STANDARD_DEVIATION 165.71 • n=7 Participants
|
318.93 Percent times Minutes
STANDARD_DEVIATION 188.06 • n=5 Participants
|
|
Avg %-change from pre-exercise baseline FEV1 after 1st β-agonist use & prior to 2nd β-agonist use
|
1.36 Percent change from baseline
STANDARD_DEVIATION 10.99 • n=5 Participants
|
4.78 Percent change from baseline
STANDARD_DEVIATION 10.92 • n=7 Participants
|
3.05 Percent change from baseline
STANDARD_DEVIATION 11.05 • n=5 Participants
|
|
Maximum FEV1 percent predicted
|
99.88 Percent of predicted value
STANDARD_DEVIATION 32.45 • n=5 Participants
|
100.54 Percent of predicted value
STANDARD_DEVIATION 15.61 • n=7 Participants
|
100.21 Percent of predicted value
STANDARD_DEVIATION 25.49 • n=5 Participants
|
|
Maximum percent fall in FEV1 after exercise
|
24.77 Percent change from baseline
STANDARD_DEVIATION 10.25 • n=5 Participants
|
25.42 Percent change from baseline
STANDARD_DEVIATION 9.04 • n=7 Participants
|
25.09 Percent change from baseline
STANDARD_DEVIATION 9.65 • n=5 Participants
|
|
Time to recovery
|
23.53 Minutes
STANDARD_DEVIATION 10.53 • n=5 Participants
|
21.51 Minutes
STANDARD_DEVIATION 8.30 • n=7 Participants
|
22.53 Minutes
STANDARD_DEVIATION 9.51 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)Population: The primary efficacy analysis was based on the full analysis set (FAS) population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.
The effect of four weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on EIB as measured by the maximum post-exercise percent fall (relative to pre-exercise baseline) in FEV1.
Outcome measures
| Measure |
Montelukast
n=144 Participants
Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
|
Salmeterol
n=144 Participants
Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
|
|---|---|---|
|
Maximum Post-exercise Percent (%) Fall in FEV1
|
10.57 Percent change from baseline
Interval 8.86 to 12.27
|
13.82 Percent change from baseline
Interval 12.11 to 15.52
|
SECONDARY outcome
Timeframe: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)Population: The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the area under the curve from 0 to 20 minutes (AUC0-20) for FEV1 percent change from pre-exercise baseline.
Outcome measures
| Measure |
Montelukast
n=144 Participants
Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
|
Salmeterol
n=144 Participants
Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
|
|---|---|---|
|
Area Under the Curve for %-Change From Pre-exercise Baseline FEV1 in Liters (L), From 0 to 20 Minutes (AUC(0-20))
|
116.04 Percent times Minutes
Interval 89.95 to 142.24
|
168.75 Percent times Minutes
Interval 142.56 to 194.95
|
SECONDARY outcome
Timeframe: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)Population: The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on short-acting β-agonist bronchodilation as measured by the maximum FEV1 percent predicted following first β-agonist use.
Outcome measures
| Measure |
Montelukast
n=144 Participants
Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
|
Salmeterol
n=144 Participants
Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
|
|---|---|---|
|
Maximum FEV1 % Predicted Following First Beta-agonist Use
|
104.03 Percent of predicted value
Interval 102.83 to 105.23
|
99.92 Percent of predicted value
Interval 98.72 to 101.12
|
SECONDARY outcome
Timeframe: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)Population: The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the time to recovery (to within 5 percent of the pre-exercise baseline FEV1) following a standardized exercise challenge.
Outcome measures
| Measure |
Montelukast
n=144 Participants
Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
|
Salmeterol
n=144 Participants
Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
|
|---|---|---|
|
Time to Recovery to Within 5% of Baseline FEV1
|
5.9 minutes
Interval 0.0 to 19.12
|
11.1 minutes
Interval 0.065 to 22.94
|
SECONDARY outcome
Timeframe: 4 weeks (Weeks 0 to 4 or Weeks 6 to 10)Population: The secondary efficacy analysis was based on the FAS population which included all randomized participants who took at least one dose of post randomization study drug and had a measurement for analysis available in both treatment periods of the cross-over design.
The effect of a four-week treatment course of oral montelukast plus inhaled fluticasone, compared to inhaled salmeterol plus inhaled fluticasone, on the extent and severity of EIB as measured by the average percent change in FEV1 after first β-agonist intake and prior to second β-agonist use.
Outcome measures
| Measure |
Montelukast
n=144 Participants
Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
|
Salmeterol
n=144 Participants
Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
|
|---|---|---|
|
Average (Avg) %-Change in FEV1 After First Beta (β)-Agonist Use and Prior to Second β-agonist Use
|
6.51 Percent change from baseline
Interval 5.44 to 7.59
|
2.72 Percent change from baseline
Interval 1.64 to 3.79
|
Adverse Events
Montelukast
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Salmeterol
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Montelukast
n=150 participants at risk
Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks.
Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks.
Inhaled Fluticasone 100 mcg twice daily throughout the study.
|
Salmeterol
n=150 participants at risk
Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks.
Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks.
Inhaled Fluticasone 100 mcg twice daily throughout the study.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
Other adverse events
| Measure |
Montelukast
n=150 participants at risk
Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks.
Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks.
Inhaled Fluticasone 100 mcg twice daily throughout the study.
|
Salmeterol
n=150 participants at risk
Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks.
Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks.
Inhaled Fluticasone 100 mcg twice daily throughout the study.
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Eye disorders
Conjunctivitis Allergic
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/150 • Number of events 2
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
General disorders
Pyrexia
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
1.3%
2/150 • Number of events 2
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Immune system disorders
Allergy To Plants
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Infections and infestations
Candidiasis
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Infections and infestations
Ear Infection
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Infections and infestations
Influenza
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
2/150 • Number of events 2
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Infections and infestations
Pertussis
|
1.3%
2/150 • Number of events 2
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Infections and infestations
Pharyngitis
|
3.3%
5/150 • Number of events 5
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
2.0%
3/150 • Number of events 3
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Infections and infestations
Tonsillitis
|
2.0%
3/150 • Number of events 3
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
1.3%
2/150 • Number of events 2
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
1.3%
2/150 • Number of events 2
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Infections and infestations
Viral Pharyngitis
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Infections and infestations
Viral Rhinitis
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Injury, poisoning and procedural complications
Ear Injury
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Injury, poisoning and procedural complications
Fall
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Injury, poisoning and procedural complications
Skin Injury
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Nervous system disorders
Headache
|
1.3%
2/150 • Number of events 2
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Reproductive system and breast disorders
Menstruation Delayed
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.7%
4/150 • Number of events 4
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
2.7%
4/150 • Number of events 4
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/150
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
0.67%
1/150 • Number of events 1
154 participants (pts) enrolled, but only 150 took at least 1 dose of each treatment (tx). 78 pts were in Montelukast (M)/Salmeterol (S) sequence (seq) and 76 in S/M seq. 4 pts in M/S seq only took 1st tx; so 78 took M \& 74 took S. 4 different pts in S/M seq only took 1st tx; so 76 took S \& 72 took M. Total of 150 pts took M and 150 took S.
|
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 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. The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER