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| ID | Type | Description | Link |
|---|---|---|---|
| 2004_009 |
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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 patients 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 |
|
| 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 Post-dose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) | In patients with EIB, the percent change from pre-exercise baseline FEV, 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 Patients 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 Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose |
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Inclusion Criteria:
Exclusion Criteria:
the patient may not participate
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17454341 | Background | Philip G, Villaran C, Pearlman DS, Loeys T, Dass SB, Reiss TF. Protection against exercise-induced bronchoconstriction two hours after a single oral dose of montelukast. J Asthma. 2007 Apr;44(3):213-7. doi: 10.1080/02770900701209806. |
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Patients who required excluded medications, or did not meet 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 8 sites (7 in the US and 1 in Peru).
Primary therapy period: May to October 2004.
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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 in the morning as a single witnessed dose. This was followed by a 3-7 day washout period and then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally in the morning 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 in the morning as a single witnessed dose. This was followed by a 3-7 day washout and then a montelukast 10-mg tablet (Treatment Period II) was taken orally in the morning 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 |
|
| 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 Post-dose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) | In patients with EIB, the percent change from pre-exercise baseline FEV, 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 | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose |
|
Adverse events (AEs) were collected during Period I and Period II, and up to and including 14 days after the last dose of study therapy
The number of participants listed in the AE table (58 montelukast & 57 placebo) is the number that received treatment.
Although a participant may have 2 or more AEs they are counted only once in a category. The same participant may appear in other 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 10 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (7.0) | Non-systematic Assessment |
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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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| 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 Patients 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 EIB | In patients with EIB, the percent change from pre-exercise baseline FEV, 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 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. | 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 0-60 Min) 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 0-60 Min) 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 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 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 after exercise challenge 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 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 |
| Withdrawal by Subject |
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| Other |
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| NOT COMPLETED |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Need for β-agonist rescue medication following exercise challenge | Number | Participants |
|
| 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 (L)] measured on the day of the exercise challenge, 5 minutes before exercise testing. | Mean | Standard Deviation | percent change from pre-exercise measure |
|
| 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 | Montelukast 10 mg | All Montelukast 10 mg patients from Treatment Periods I and II |
|
|
| Secondary | Number of Patients 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 Patients 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 Patients 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 |
|
|
|
| Secondary | Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline 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 (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 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 | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose |
|
|
|
| Secondary | Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline 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 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 | Pre-exercise baseline measurement and 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 change) *minutes | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 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 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 |
|
|
|
| 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 was an 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 |
|
|
|
| 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 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 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 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 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 |
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| 0 |
| 58 |
| 1 |
| 58 |
| EG001 | Placebo | 0 | 57 | 3 | 57 |
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 |