| Primary | Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose | Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins (minutes) after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication. The calculation used to produce the results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy. | The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods. | Posted | | Mean | Standard Deviation | Percent fall in FEV1 | | Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose | | | | ID | Title | Description |
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| OG000 | Montelukast | In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days. | | OG001 | Placebo | In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00015.35± 9.47(12.60 to 18.11)
- OG00120.00± 15.75(17.25 to 22.76)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | ANOVA | | 0.020 | | Difference in least square means | -4.65 | | | | 95 | | | | | Montelukast minus placebo | | Superiority or Other (legacy) | | |
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| Secondary | Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose | Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication. The calculation used to produce the resulted results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy. | The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods. | Posted | | Mean | Standard Deviation | percent fall in FEV1 | | Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Montelukast | In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days. | | OG001 |
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| Secondary | Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose | AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy. | The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods. | Posted | | Mean | Standard Deviation | percent fall * minute | | Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose | | | | ID | Title | Description |
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| OG000 | Montelukast | In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days. | |
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| Secondary | Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose | AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy. | The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods. | Posted | | Mean | Standard Deviation | percent fall * minute | | Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose | | | | ID | Title | Description |
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| OG000 | Montelukast | In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days. | |
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| Secondary | Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose | This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time. Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of medication. | The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods. | Posted | | Mean | Standard Deviation | Minutes | | 0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose | | | | ID | Title | Description |
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| OG000 | Montelukast | In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days. | | OG001 | Placebo |
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| Secondary | Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose | This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time. Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45 & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of medication. | The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods. | Posted | | Mean | Standard Deviation | Minutes | | 0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose | | | | ID | Title | Description |
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| OG000 | Montelukast | In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days. | | OG001 | Placebo |
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| Secondary | Number of Participants Requiring Rescue Medication at 2 Hours Postdose | This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication. | The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods. | Posted | | Number | | participants | | 0-90 minutes after the exercise challenge at 2 hours postdose | | | | ID | Title | Description |
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| OG000 | Montelukast | In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days. | | OG001 | Placebo | In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days. |
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| Secondary | Number of Participants Requiring Rescue Medication at 24 Hours Postdose | This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication. | The analysis of efficacy data was carried out using a completers analysis population. This population included all randomized patients who received the witnessed dose of study drug in both active treatment periods and had at least one post-exercise FEV1 measurement in both active treatment periods. | Posted | | Number | | Participants | | 0-90 minutes after the exercise challenge at 24 hours postdose | | | | ID | Title | Description |
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| OG000 | Montelukast | In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days. | | OG001 | Placebo | In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days. |
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