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| ID | Type | Description | Link |
|---|---|---|---|
| MK0476-270 | |||
| 2004_026 |
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The purpose of this study is 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 participants who have a history of worsening asthma after exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Montelukast - Placebo |
|
| 2 | Experimental | Placebo - Montelukast |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Montelukast | Drug | Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) | In Participants 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. | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose | 0-90 minutes after the exercise challenge performed at 2 hours postdose | |
| Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 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 |
|---|---|---|---|
| 16892789 | Background | Pearlman DS, van Adelsberg J, Philip G, Tilles SA, Busse W, Hendeles L, Loeys T, Dass SB, Reiss TF. Onset and duration of protection against exercise-induced bronchoconstriction by a single oral dose of montelukast. Ann Allergy Asthma Immunol. 2006 Jul;97(1):98-104. doi: 10.1016/S1081-1206(10)61377-4. |
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Patients who required excluded medications, or did not meet forced expiratory volume in 1 second (FEV1) criteria during the prestudy period were excluded from randomization. Patients who required a β-agonist after the exercise challenge and did not meet FEV1 criteria within 30 minutes of treatment were also excluded.
Patients were randomized at 9 sites.
Primary therapy period: July to November 2003
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast 10 mg in Period I Then Placebo in Period II | A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose. |
| FG001 | Placebo in Period I Then Montelukast 10 mg in Period II | A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period I |
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| Treatment Period II |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | All randomized patients |
| Units | Counts |
|---|---|
| Participants |
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| 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 FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) | In Participants 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 a 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 | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose |
|
During Period I and II (2 day treatment periods) and the 3 to 7 day crossover washout period, and up to and including 14 days after the last dose of study therapy.
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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 10 mg in Period I Then Placebo in Period II | A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
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| ID | Term |
|---|---|
| D001250 | Asthma, Exercise-Induced |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Comparator: Placebo | Drug | Placebo tablet administered orally as a single witnessed dose before exercise challenge |
|
| 0-90 minutes after the exercise challenge performed at 12 hours postdose |
| Number of Participants Requiring ß-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 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) | In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose |
| Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) | In patients with EIB, the percent change from pre-exercise baseline FEV1 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. | Pre-exercise baseline measurement and 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 0-60min) at 2 Hours Postdose | The measure included only the area below the pre-exercise baseline. | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose |
| Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose | The measure included only the area below the pre-exercise baseline. | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose |
| Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose | The measure included only the area below the pre-exercise baseline. | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 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 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 12 Hours Postdose | The time to recovery from maximum percent fall is 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. | Exercise challenge at 12 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 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. | Exercise challenge at 24 hours postdose |
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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 |
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| AUC for percent change from pre-exercise measurement FEV1 in L 0-60 mins after exercise challenge | Area under the curve (AUC) for FEV1 percent change from pre-exercise measurement over the first hour after exercise challenge. | Mean | Standard Deviation | (percent change) *minutes |
|
| Maximum Percent Fall in forced expiratory volume in 1 second (FEV1) post-exercise challenge | Maximum percent fall in FEV1 from pre-exercise measurement occurring within the first 60 minutes after exercise challenge. Pre-exercise measurement FEV1 is the value (in liters) measured on the day of the exercise challenge, 5 minutes before exercise testing. | Mean | Standard Deviation | Percent change from pre-exercise measure |
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| Time to recovery from maximal percent fall in FEV1 after exercise challenge | The duration between the time at which the maximum percent fall in FEV1 occurs and the time when the FEV1 returns to within 5% of the pre-exercise measurement for the first time after the exercise challenge | Mean | Standard Deviation | Minutes |
|
| OG001 | Montelukast 10 mg | All Montelukast 10 mg patients from Treatment Periods I and II |
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| Secondary | Number of Participants Requiring ß-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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| Secondary | Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 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 12 hours postdose |
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| Secondary | Number of Participants Requiring ß-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 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) | In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (12 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 a 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 | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose |
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| Secondary | Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) | In patients with EIB, the percent change from pre-exercise baseline FEV1 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 primary 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 | Percent Change | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose |
|
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| Secondary | Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) 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 change) *minutes | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 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 0-60min) at 12 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 change) *minutes | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 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 0-60min) 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 change) *minutes | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose |
|
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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 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 12 Hours Postdose | The time to recovery from maximum percent fall is 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. | 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 12 hours postdose |
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| 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 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 |
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| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Placebo in Period I Then Montelukast 10 mg in Period II | A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose. | 0 | 26 | 0 | 26 |
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 |