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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-316 | |||
| 2005_043 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Montelukast - Salmeterol - Placebo |
|
| 2 | Experimental | Montelukast - Placebo - Salmeterol |
|
| 3 | Experimental | Salmeterol - Montelukast - Placebo |
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| 4 | Experimental | Salmeterol - Placebo - Montelukast |
|
| 5 | Experimental | Placebo - Montelukast - Salmeterol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Montelukast | Drug | 1 dose montelukast 10 mg tablet given orally in one of three treatment periods |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17573489 | Background | Philip G, Pearlman DS, Villaran C, Legrand C, Loeys T, Langdon RB, Reiss TF. Single-dose montelukast or salmeterol as protection against exercise-induced bronchoconstriction. Chest. 2007 Sep;132(3):875-83. doi: 10.1378/chest.07-0550. Epub 2007 Jun 15. |
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Patients who required excluded medications, or did not meet FEV1 criteria during the prestudy period were excluded from randomization.
Patients were randomized at 5 sites (4 in the US and 1 in Peru).
Primary therapy period: December 2005 to August 2006
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast/ Salmeterol/Placebo | 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. |
| FG001 | Montelukast/ Placebo/ Salmeterol | 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. |
| FG002 | Salmeterol / Montelukast/ Placebo | 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. |
| FG003 | Salmeterol/ Placebo/ Montelukast | 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. |
| FG004 | Placebo/ Montelukast/ Salmeterol | 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. |
| FG005 | Placebo/ Salmeterol/ Montelukast | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period II |
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| Washout Between Periods II and III |
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| Treatment Period III |
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| Washout Between Periods III and IV |
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| Treatment Period IV |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | All randomized patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | 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. | 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. | Posted | Mean | Standard Deviation | Percent Change from Baseline | 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose |
|
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.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Montelukast/ Salmeterol/Placebo | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001250 | Asthma, Exercise-Induced |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C093875 | montelukast |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 |
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| 6 | Experimental | Placebo - Salmeterol - Montelukast |
|
| Comparator: Salmeterol | Drug | 1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods |
|
| Comparator: Placebo (montelukast) | Drug | 1 dose matching-image placebo to montelukast tablet in two of three treatment periods |
|
| Comparator: Placebo (salmeterol) | Drug | 1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods |
|
| 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 | 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. | 0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose |
| Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB | 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. | 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose |
| 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 | The measure included only the area below the pre-exercise baseline | 0-60 minutes after the exercise challenge at 2 hours postdose |
| 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 | The measure included only the area below the pre-exercise baseline | 0-60 minutes after the exercise challenge at 8.5 hours postdose |
| 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 | The measure included only the area below the pre-exercise baseline | 0-60 minutes after the exercise challenge at 24 hours postdose |
| Time to Recovery From Maximum Percentage Decrease in FEV1 After 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. | Exercise challenge at 2 hours postdose |
| Time to Recovery From Maximum Percentage Decrease in FEV1 After 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. | Exercise challenge at 8.5 hours postdose |
| Time to Recovery From Maximum Percentage Decrease in FEV1 After 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. | Exercise challenge at 24 hours postdose |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Need for β-agonist rescue medication following exercise challenge | Number | participants |
|
| Area under the FEV1 percent change from baseline time curve for 0-60 mins after exercise challenge | Mean | Standard Deviation | % * minutes |
|
| Maximum percent fall in forced expiratory volume in 1 second (FEV1) post-exercise challenge | Mean | Standard Deviation | Percent Change from Baseline |
|
| Time to recovery from maximal percent fall | The duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. | Mean | Standard Deviation | Minutes |
|
| OG001 | Salmeterol 50-μg | All Salmeterol 50-μg patients from all Treatment Periods. |
| OG002 | Placebo | All Placebo patients from all Treatment Periods. |
|
|
| Secondary | Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose | 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. | Posted | Number | Participants | 0-90 minutes after the exercise challenge performed at 2 hours postdose |
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|
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| Secondary | Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose | 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. | Posted | Number | Participants | 0-90 minutes after the exercise challenge performed at 8.5 hours postdose |
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| Secondary | Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose | 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. | Posted | Number | Participants | 0-90 minutes after the exercise challenge performed at 24 hours postdose |
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| Secondary | Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB | 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. | 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. | Posted | Mean | Standard Deviation | Percent Change from Baseline | 0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose |
|
|
|
| Secondary | Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB | 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. | 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. | Posted | Mean | Standard Deviation | Percent Change from Baseline | 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose |
|
|
|
| Secondary | 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 | The measure included only the area below the pre-exercise baseline | 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. | Posted | Mean | Standard Deviation | Percent * minutes | 0-60 minutes after the exercise challenge at 2 hours postdose |
|
|
|
| Secondary | 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 | The measure included only the area below the pre-exercise baseline | 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. | Posted | Mean | Standard Deviation | Percent * minutes | 0-60 minutes after the exercise challenge at 8.5 hours postdose |
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| Secondary | 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 | The measure included only the area below the pre-exercise baseline | 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. | Posted | Mean | Standard Deviation | Percent * minutes | 0-60 minutes after the exercise challenge at 24 hours postdose |
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|
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| Secondary | Time to Recovery From Maximum Percentage Decrease in FEV1 After 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. | 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. | Posted | Mean | Standard Deviation | Minutes | Exercise challenge at 2 hours postdose |
|
|
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| Secondary | Time to Recovery From Maximum Percentage Decrease in FEV1 After 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. | 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. | Posted | Mean | Standard Deviation | Minutes | Exercise challenge at 8.5 hours postdose |
|
|
|
| Secondary | Time to Recovery From Maximum Percentage Decrease in FEV1 After 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. | 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. | Posted | Mean | Standard Deviation | Minutes | Exercise challenge at 24 hours postdose |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Montelukast/ Placebo/ Salmeterol | 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. | 0 | 8 | 0 | 8 |
| EG002 | Salmeterol / Montelukast/ Placebo | 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. | 0 | 8 | 0 | 8 |
| EG003 | Salmeterol/ Placebo/ Montelukast | 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. | 0 | 8 | 0 | 8 |
| EG004 | Placebo/ Montelukast/ Salmeterol | 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. | 0 | 8 | 0 | 8 |
| EG005 | Placebo/ Salmeterol/ Montelukast | 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. | 0 | 8 | 0 | 8 |
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.
| D000092202 |
| Exercise-Induced Allergies |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
|
|
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