Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)
Study Details
Study Description
Brief Summary
To determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have a history of worsening asthma after exercise.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1 Montelukast - Salmeterol - Placebo |
Drug: Comparator: Montelukast
1 dose montelukast 10 mg tablet given orally in one of three treatment periods
Drug: Comparator: Salmeterol
1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods
Drug: Comparator: Placebo (montelukast)
1 dose matching-image placebo to montelukast tablet in two of three treatment periods
Drug: Comparator: Placebo (salmeterol)
1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
|
Experimental: 2 Montelukast - Placebo - Salmeterol |
Drug: Comparator: Montelukast
1 dose montelukast 10 mg tablet given orally in one of three treatment periods
Drug: Comparator: Salmeterol
1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods
Drug: Comparator: Placebo (montelukast)
1 dose matching-image placebo to montelukast tablet in two of three treatment periods
Drug: Comparator: Placebo (salmeterol)
1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
|
Experimental: 3 Salmeterol - Montelukast - Placebo |
Drug: Comparator: Montelukast
1 dose montelukast 10 mg tablet given orally in one of three treatment periods
Drug: Comparator: Salmeterol
1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods
Drug: Comparator: Placebo (montelukast)
1 dose matching-image placebo to montelukast tablet in two of three treatment periods
Drug: Comparator: Placebo (salmeterol)
1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
|
Experimental: 4 Salmeterol - Placebo - Montelukast |
Drug: Comparator: Montelukast
1 dose montelukast 10 mg tablet given orally in one of three treatment periods
Drug: Comparator: Salmeterol
1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods
Drug: Comparator: Placebo (montelukast)
1 dose matching-image placebo to montelukast tablet in two of three treatment periods
Drug: Comparator: Placebo (salmeterol)
1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
|
Experimental: 5 Placebo - Montelukast - Salmeterol |
Drug: Comparator: Montelukast
1 dose montelukast 10 mg tablet given orally in one of three treatment periods
Drug: Comparator: Salmeterol
1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods
Drug: Comparator: Placebo (montelukast)
1 dose matching-image placebo to montelukast tablet in two of three treatment periods
Drug: Comparator: Placebo (salmeterol)
1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
|
Experimental: 6 Placebo - Salmeterol - Montelukast |
Drug: Comparator: Montelukast
1 dose montelukast 10 mg tablet given orally in one of three treatment periods
Drug: Comparator: Salmeterol
1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods
Drug: Comparator: Placebo (montelukast)
1 dose matching-image placebo to montelukast tablet in two of three treatment periods
Drug: Comparator: Placebo (salmeterol)
1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
|
Outcome Measures
Primary Outcome Measures
- Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB) [0-60 minutes after the exercise challenge performed 2 hours after a single oral dose]
In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
Secondary Outcome Measures
- Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose [0-90 minutes after the exercise challenge performed at 2 hours postdose]
- Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose [0-90 minutes after the exercise challenge performed at 8.5 hours postdose]
- Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose [0-90 minutes after the exercise challenge performed at 24 hours postdose]
- Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB [0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose]
In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (8.5 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
- Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB [0-60 minutes after the exercise challenge performed 24 hours after a single oral dose]
In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.
- Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose [0-60 minutes after the exercise challenge at 2 hours postdose]
The measure included only the area below the pre-exercise baseline
- Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose [0-60 minutes after the exercise challenge at 8.5 hours postdose]
The measure included only the area below the pre-exercise baseline
- Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose [0-60 minutes after the exercise challenge at 24 hours postdose]
The measure included only the area below the pre-exercise baseline
- Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose [Exercise challenge at 2 hours postdose]
The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
- Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose [Exercise challenge at 8.5 hours postdose]
The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
- Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose [Exercise challenge at 24 hours postdose]
The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Physician-diagnosed exercise-induced bronchospasm
Exclusion Criteria:
- Patient is, other than asthma, not in good, stable health. The Primary Investigator will evaluate whether there are other reasons why the patient may not participate.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Organon and Co
Investigators
- Study Director: Medical Monitor, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
None provided.More Information
Publications
- 0476-316
- MK0476-316
- 2005_043
Study Results
Participant Flow
Recruitment Details | Patients were randomized at 5 sites (4 in the US and 1 in Peru). Primary therapy period: December 2005 to August 2006 |
---|---|
Pre-assignment Detail | Patients who required excluded medications, or did not meet FEV1 criteria during the prestudy period were excluded from randomization. |
Arm/Group Title | Montelukast/ Salmeterol/Placebo | Montelukast/ Placebo/ Salmeterol | Salmeterol / Montelukast/ Placebo | Salmeterol/ Placebo/ Montelukast | Placebo/ Montelukast/ Salmeterol | Placebo/ Salmeterol/ Montelukast |
---|---|---|---|---|---|---|
Arm/Group Description | During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder. Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III. During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder. Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV. During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. | During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder. Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III. During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV. During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder. | During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder. Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III. During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder. Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV. During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. | During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder. Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III. During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV. During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder. | During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III. During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder. Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV. During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder. | During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III. During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder. Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV. During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder. |
Period Title: Treatment Period II | ||||||
STARTED | 7 | 8 | 8 | 8 | 8 | 8 |
COMPLETED | 7 | 8 | 8 | 8 | 8 | 8 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Treatment Period II | ||||||
STARTED | 7 | 8 | 8 | 8 | 8 | 8 |
COMPLETED | 7 | 8 | 8 | 8 | 8 | 8 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Treatment Period II | ||||||
STARTED | 7 | 8 | 8 | 8 | 8 | 8 |
COMPLETED | 7 | 8 | 8 | 8 | 8 | 8 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Treatment Period II | ||||||
STARTED | 7 | 8 | 8 | 8 | 8 | 8 |
COMPLETED | 7 | 7 | 8 | 8 | 8 | 8 |
NOT COMPLETED | 0 | 1 | 0 | 0 | 0 | 0 |
Period Title: Treatment Period II | ||||||
STARTED | 7 | 7 | 8 | 8 | 8 | 8 |
COMPLETED | 7 | 7 | 8 | 8 | 8 | 8 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Overall Study Population |
---|---|
Arm/Group Description | All randomized patients |
Overall Participants | 47 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
26.0
(7.92)
|
Sex: Female, Male (Count of Participants) | |
Female |
24
51.1%
|
Male |
23
48.9%
|
Need for β-agonist rescue medication following exercise challenge (participants) [Number] | |
No |
31
66%
|
Yes |
16
34%
|
Area under the FEV1 percent change from baseline time curve for 0-60 mins after exercise challenge (% * minutes) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [% * minutes] |
957.46
(518.69)
|
Maximum percent fall in forced expiratory volume in 1 second (FEV1) post-exercise challenge (Percent Change from Baseline) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Percent Change from Baseline] |
27.75
(6.26)
|
Time to recovery from maximal percent fall (Minutes) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Minutes] |
55.03
(32.62)
|
Outcome Measures
Title | Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB) |
---|---|
Description | In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. |
Time Frame | 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose |
Outcome Measure Data
Analysis Population Description |
---|
The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis. |
Arm/Group Title | Montelukast 10 mg | Salmeterol 50-μg | Placebo |
---|---|---|---|
Arm/Group Description | All Montelukast 10 mg patients from all Treatment Periods. | All Salmeterol 50-μg patients from all Treatment Periods. | All Placebo patients from all Treatment Periods. |
Measure Participants | 47 | 46 | 47 |
Mean (Standard Deviation) [Percent Change from Baseline] |
13.15
(10.28)
|
10.46
(9.95)
|
21.86
(13.44)
|
Title | Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose |
---|---|
Description | |
Time Frame | 0-90 minutes after the exercise challenge performed at 2 hours postdose |
Outcome Measure Data
Analysis Population Description |
---|
The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis. |
Arm/Group Title | Montelukast 10 mg | Salmeterol 50-μg | Placebo |
---|---|---|---|
Arm/Group Description | All Montelukast 10 mg patients from all Treatment Periods. | All Salmeterol 50-μg patients from all Treatment Periods. | All Placebo patients from all Treatment Periods. |
Measure Participants | 47 | 46 | 47 |
Patients Requiring Rescue Medication |
3
6.4%
|
4
NaN
|
9
NaN
|
Patients Not Requiring Rescue Medication |
44
93.6%
|
42
NaN
|
38
NaN
|
Title | Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose |
---|---|
Description | |
Time Frame | 0-90 minutes after the exercise challenge performed at 8.5 hours postdose |
Outcome Measure Data
Analysis Population Description |
---|
The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis. |
Arm/Group Title | Montelukast 10 mg | Salmeterol 50-μg | Placebo |
---|---|---|---|
Arm/Group Description | All Montelukast 10 mg patients from all Treatment Periods. | All Salmeterol 50-μg patients from all Treatment Periods. | All Placebo patients from all Treatment Periods. |
Measure Participants | 40 | 39 | 37 |
Patients Requiring Rescue Medication |
0
0%
|
0
NaN
|
4
NaN
|
Patients Not Requiring Rescue Medication |
40
85.1%
|
39
NaN
|
33
NaN
|
Title | Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose |
---|---|
Description | |
Time Frame | 0-90 minutes after the exercise challenge performed at 24 hours postdose |
Outcome Measure Data
Analysis Population Description |
---|
The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis. |
Arm/Group Title | Montelukast 10 mg | Salmeterol 50-μg | Placebo |
---|---|---|---|
Arm/Group Description | All Montelukast 10 mg patients from all Treatment Periods. | All Salmeterol 50-μg patients from all Treatment Periods. | All Placebo patients from all Treatment Periods. |
Measure Participants | 46 | 46 | 46 |
Patients Requiring Rescue Medication |
3
6.4%
|
6
NaN
|
6
NaN
|
Patients Not Requiring Rescue Medication |
43
91.5%
|
40
NaN
|
40
NaN
|
Title | Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB |
---|---|
Description | In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (8.5 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. |
Time Frame | 0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose |
Outcome Measure Data
Analysis Population Description |
---|
The secondary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis. |
Arm/Group Title | Montelukast 10 mg | Salmeterol 50-μg | Placebo |
---|---|---|---|
Arm/Group Description | All Montelukast 10 mg patients from all Treatment Periods. | All Salmeterol 50-μg patients from all Treatment Periods. | All Placebo patients from all Treatment Periods. |
Measure Participants | 40 | 39 | 37 |
Mean (Standard Deviation) [Percent Change from Baseline] |
11.60
(9.64)
|
11.01
(7.56)
|
16.65
(12.76)
|
Title | Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB |
---|---|
Description | In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. |
Time Frame | 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose |
Outcome Measure Data
Analysis Population Description |
---|
The secondary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis. |
Arm/Group Title | Montelukast 10 mg | Salmeterol 50-μg | Placebo |
---|---|---|---|
Arm/Group Description | All Montelukast 10 mg patients from all Treatment Periods. | All Salmeterol 50-μg patients from all Treatment Periods. | All Placebo patients from all Treatment Periods. |
Measure Participants | 46 | 46 | 46 |
Mean (Standard Deviation) [Percent Change from Baseline] |
10.09
(11.10)
|
16.22
(13.09)
|
13.64
(9.67)
|
Title | Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose |
---|---|
Description | The measure included only the area below the pre-exercise baseline |
Time Frame | 0-60 minutes after the exercise challenge at 2 hours postdose |
Outcome Measure Data
Analysis Population Description |
---|
The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis. |
Arm/Group Title | Montelukast 10 mg | Salmeterol 50-μg | Placebo |
---|---|---|---|
Arm/Group Description | All Montelukast 10 mg patients from all Treatment Periods. | All Salmeterol 50-μg patients from all Treatment Periods. | All Placebo patients from all Treatment Periods. |
Measure Participants | 47 | 46 | 47 |
Mean (Standard Deviation) [Percent * minutes] |
254.60
(241.17)
|
293.05
(362.33)
|
710.43
(529.91)
|
Title | Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose |
---|---|
Description | The measure included only the area below the pre-exercise baseline |
Time Frame | 0-60 minutes after the exercise challenge at 8.5 hours postdose |
Outcome Measure Data
Analysis Population Description |
---|
The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis. |
Arm/Group Title | Montelukast 10 mg | Salmeterol 50-μg | Placebo |
---|---|---|---|
Arm/Group Description | All Montelukast 10 mg patients from all Treatment Periods. | All Salmeterol 50-μg patients from all Treatment Periods. | All Placebo patients from all Treatment Periods. |
Measure Participants | 40 | 39 | 37 |
Mean (Standard Deviation) [Percent * minutes] |
191.01
(166.24)
|
276.26
(226.37)
|
511.28
(566.30)
|
Title | Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose |
---|---|
Description | The measure included only the area below the pre-exercise baseline |
Time Frame | 0-60 minutes after the exercise challenge at 24 hours postdose |
Outcome Measure Data
Analysis Population Description |
---|
The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis. |
Arm/Group Title | Montelukast 10 mg | Salmeterol 50-μg | Placebo |
---|---|---|---|
Arm/Group Description | All Montelukast 10 mg patients from all Treatment Periods. | All Salmeterol 50-μg patients from all Treatment Periods. | All Placebo patients from all Treatment Periods. |
Measure Participants | 46 | 46 | 46 |
Mean (Standard Deviation) [Percent * minutes] |
231.09
(413.73)
|
554.93
(649.52)
|
395.96
(464.92)
|
Title | Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose |
---|---|
Description | The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. |
Time Frame | Exercise challenge at 2 hours postdose |
Outcome Measure Data
Analysis Population Description |
---|
The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis. |
Arm/Group Title | Montelukast 10 mg | Salmeterol 50-μg | Placebo |
---|---|---|---|
Arm/Group Description | All Montelukast 10 mg patients from all Treatment Periods. | All Salmeterol 50-μg patients from all Treatment Periods. | All Placebo patients from all Treatment Periods. |
Measure Participants | 47 | 46 | 47 |
Mean (Standard Deviation) [Minutes] |
16.63
(23.72)
|
17.58
(27.81)
|
42.70
(34.26)
|
Title | Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose |
---|---|
Description | The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. |
Time Frame | Exercise challenge at 8.5 hours postdose |
Outcome Measure Data
Analysis Population Description |
---|
The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis. |
Arm/Group Title | Montelukast 10 mg | Salmeterol 50-μg | Placebo |
---|---|---|---|
Arm/Group Description | All Montelukast 10 mg patients from all Treatment Periods. | All Salmeterol 50-μg patients from all Treatment Periods. | All Placebo patients from all Treatment Periods. |
Measure Participants | 40 | 39 | 37 |
Mean (Standard Deviation) [Minutes] |
10.70
(13.38)
|
13.82
(18.37)
|
32.34
(34.57)
|
Title | Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose |
---|---|
Description | The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. |
Time Frame | Exercise challenge at 24 hours postdose |
Outcome Measure Data
Analysis Population Description |
---|
The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis. |
Arm/Group Title | Montelukast 10 mg | Salmeterol 50-μg | Placebo |
---|---|---|---|
Arm/Group Description | All Montelukast 10 mg patients from all Treatment Periods. | All Salmeterol 50-μg patients from all Treatment Periods. | All Placebo patients from all Treatment Periods. |
Measure Participants | 46 | 46 | 46 |
Mean (Standard Deviation) [Minutes] |
11.04
(20.84)
|
29.75
(33.50)
|
23.31
(29.30)
|
Adverse Events
Time Frame | Periods II through IV and washout periods in between these treatment periods, and up to and including 14 days after the last dose of study therapy. | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | Although a patient may have had two or more adverse experiences the patient is counted only once in a category. The same patient may appear in different categories. | |||||||||||
Arm/Group Title | Montelukast/ Salmeterol/Placebo | Montelukast/ Placebo/ Salmeterol | Salmeterol / Montelukast/ Placebo | Salmeterol/ Placebo/ Montelukast | Placebo/ Montelukast/ Salmeterol | Placebo/ Salmeterol/ Montelukast | ||||||
Arm/Group Description | During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder. Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III. During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder. Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV. During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. | During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder. Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III. During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV. During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder. | During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder. Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III. During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder. Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV. During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. | During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder. Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III. During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV. During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder. | During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III. During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder. Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV. During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder. | During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III. During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder. Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV. During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder. | ||||||
All Cause Mortality |
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Montelukast/ Salmeterol/Placebo | Montelukast/ Placebo/ Salmeterol | Salmeterol / Montelukast/ Placebo | Salmeterol/ Placebo/ Montelukast | Placebo/ Montelukast/ Salmeterol | Placebo/ Salmeterol/ Montelukast | |||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
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Montelukast/ Salmeterol/Placebo | Montelukast/ Placebo/ Salmeterol | Salmeterol / Montelukast/ Placebo | Salmeterol/ Placebo/ Montelukast | Placebo/ Montelukast/ Salmeterol | Placebo/ Salmeterol/ Montelukast | |||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/7 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
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Montelukast/ Salmeterol/Placebo | Montelukast/ Placebo/ Salmeterol | Salmeterol / Montelukast/ Placebo | Salmeterol/ Placebo/ Montelukast | Placebo/ Montelukast/ Salmeterol | Placebo/ Salmeterol/ Montelukast | |||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/7 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Senior Vice President, Global Clinical Development |
---|---|
Organization | Merck Sharp & Dohme Corp. |
Phone | 1-800-672-6372 |
ClinicalTrialsDisclosure@merck.com |
- 0476-316
- MK0476-316
- 2005_043