| Primary | Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Observed up to Two Hours Post Dose (FEV1max%0-2) on Day 22 | The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs). The maximum percent change from baseline in FEV1 observed up to 2 hours following completion of dosing using Day 22 baseline. The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values. The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age. | Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF) | Posted | | Mean | Standard Error | percentage change from baseline | | 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing on Day 22 or last observation | | | | ID | Title | Description |
|---|
| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo-HFA-MDI four times a day for 21 days. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00012.849± 1.005
- OG0019.353± 1.017
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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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| Efficacy was declared if the test for either primary efficacy endpoint was significant at the 0.025 level. | ANCOVA | Baseline as covariate and fixed effects of treatment and pooled investigator site. | 0.0138 | In order to control the overall alpha level at the 0.05 value, each of the primary endpoints were tested separately at the 0.025 level of significance. | Mean Difference (Final Values) | 3.496 | | | 2-Sided | 95 | 0.729 | 6.262 | | | | | Superiority or Other (legacy) |
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| Primary | Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) Observed up to Two Hours Post Dose (PEFmax%0-2) on Day 22 | The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs). The maximum percent change from baseline in the PEF observed up to 2 hours following completion of dosing using Day 22 baseline. The baseline PEF was defined as the average of the test-day pre-dose baseline PEF values. The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age. | Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF) | Posted | | Mean | Standard Error | percentage change from baseline | | 30±5 and 5±2 minutes prior to dosing, and at 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing on Day 22 or last observation | | | | ID | Title | Description |
|---|
| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo-HFA-MDI four times a day for 21 days. |
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| Secondary | Maximum Percent Change From Baseline in Forced Expiratory Volume in One Second (FEV1) up to Two Hours Post-Dose (FEV1max%0-2, %) on Study Days 1 and 22 Using Observed Cases | The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs). The maximum percent change from baseline in FEV1 observed up to 2 hours following completion of dosing using test day baseline. The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values. | Observed cases (i.e. available data only) | Posted | | Mean | Standard Error | percentage change from baseline | | Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing | | | | ID | Title | Description |
|---|
| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo-HFA-MDI four times a day for 21 days. |
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| Secondary | Maximum Percent Change From Baseline in Peak Expiratory Flow (PEF) up to Two Hours Post-Dose (PEFmax%0-2) on Study Days 1 and 22 Using Observed Cases | The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. A standardized spirometer was used with the subject in the sitting or standing position (orientation had to be consistent for each subject during study visits) and wearing a nose clip. Whenever possible, evaluations were performed by the same respiratory therapist on the same calibrated spirometer at approximately the same time (±2 hrs). The maximum percent change from baseline in the PEF observed up to 2 hours following completion of dosing on study days 1 and 22. The baseline PEF was defined as the average of the test-day pre-dose baseline PEF values. The reason for the two primary endpoints was that FEV1 is difficult to obtain in children below 7 years of age. | | Posted | | Mean | Standard Error | percentage change from baseline | | Days 1 and 22: 30±5 and 5±2 minutes prior to dosing, and 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing | | | | ID | Title | Description |
|---|
| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo-HFA-MDI four times a day for 21 days. |
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| Secondary | Baseline Adjusted Area-under-the-Effect Curve for Percent of Predicted Forced Expiratory Volume in One Second (FEV1) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines | The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. Values are then expressed as the percentage of FE1 values predicted for a 'normal' population. Predicted FEV1 values were computed and adjusted for age, height and gender according to Eigen et al. for subjects 4-5 years of age and to Quanjer et al. for subjects aged 6-11 years using American Thoracic Society (ATS) criteria. The area under-the-effect curves for percent-predicted FEV1 were calculated according to the trapezoidal rule and were based on actual (not scheduled) measurement times. | Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF) | Posted | | Mean | Standard Error | Percent of Predicted FEV1 * Hours | | Baseline (Day 1 or Day 22: 35±5 and 10±2 minutes prior to dosing), Day 22 (5±2, 15±5, 30±5, 45±5, 60±10, 120±10, 240±10, and 360±10 minutes post-dosing or last observation) | | | | ID | Title | Description |
|---|
| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo HFA-MDI four times a day for 21 days. |
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| Secondary | Baseline-Adjusted Area-under-the Effect Curve for Peak Expiratory Flow (PEF) Over 6 Hours Post-dose on Day 22 Using Both Day 1 and Day 22 Baselines | The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. The area under-the-effect curves for PEF were calculated according to the trapezoidal rule and were based on actual (not scheduled) measurement times. | Intent-To-Treat (ITT) population with Last Observation Carried Forward (LOCF) | Posted | | Mean | Standard Error | Liters/Minute*Hours | | Baseline (Day 1 or Day 22: 30±5 and 5±2 minutes prior to dosing Day 22: 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing or last observation | | | | ID | Title | Description |
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| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo HFA-MDI four times a day for 21 days. |
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| Secondary | Maximum Percent-Predicted FEV1 (Max PPFEV1, %) Observed up to Two Hours Following Completion of Dosing on Study Days 1 and 22 (Observed Case) | The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. Values are then expressed as the percentage of FE1 values predicted for a 'normal' population. Predicted FEV1 values were computed and adjusted for age, height and gender according to Eigen et al. for subjects 4-5 years of age and to Quanjer et al. for subjects aged 6-11 years using American Thoracic Society (ATS) criteria. | Observed cases (i.e. available data only) | Posted | | Mean | Standard Error | percentage of predicted FEV1 | | Days 1 and 22: 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing | | | | ID | Title | Description |
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| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo-HFA-MDI four times a day for 21 days. |
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| Secondary | Time To Maximum Forced Expiratory Volume in One Second (FEV1) Over Six Hours Post-Dose On Days 1 and 22 | The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. Time to maximum FEV1 is defined as the number of minutes required for the baseline FEV1 to increase to the highest FEV1 post dose during the 6 hour observation period. Median time and confidence intervals obtained via separate Kaplan-Meier estimates for each study day. | Intent-To-Treat (ITT) population; Last Observation Carried Forward (LOCF) used for Day 22 | Posted | | Median | 95% Confidence Interval | minutes | | Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5, 45±5, 60±10, 120 ±10 post dosing | | | | ID | Title | Description |
|---|
| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo HFA-MDI four times a day for 21 days. |
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| Secondary | Time To Maximum Peak Expiratory Flow (PEF) Over Six Hours Post-Dose On Days 1 and 22 | The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. Time to maximum PEF is defined as the number of minutes required for the baseline PEF to increase to the highest PEF post-dose for the 6 hour observation period. Median time and confidence intervals obtained via separate Kaplan-Meier estimates for each study day. | ITT population; Last Observation Carried Forward (LOCF) used for Day 22 | Posted | | Median | 95% Confidence Interval | minutes | | Days 1 and 22: 30±5 and 5±2 minutes prior to dosing, and 7.5±2, 20±5, 35±5, 50±5, 65±10, 125±10 post dosing | | | | ID | Title | Description |
|---|
| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo HFA-MDI four times a day for 21 days. |
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| Secondary | Participant Responses: Percentage of Participants With a >=15% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22 | The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. This outcome counts participants who responded to therapy by obtaining a >+15% increase in FEV1 within 30 minutes of dose. The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values. | | Posted | | Number | | percentage of participants | | Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing | | | | ID | Title | Description |
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| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo HFA-MDI four times a day for 21 days. |
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| Secondary | Participant Responses: Percentage of Participants With a >=12% Increase in Baseline FEV1 Within 30 Minutes Post-Dose on Days 1 and 22 | The FEV1 test is conducted by having a person empty their lungs of air into a mouthpiece attached to a sensor that measures the amount of air blown measured in liters. This outcome counts participants who responded to therapy by obtaining a >+12% increase in FEV1 within 30 minutes of dose. The baseline FEV1 was defined as the average of the two test-day pre-dose baseline FEV1 values. | | Posted | | Number | | percentage of participants | | Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing | | | | ID | Title | Description |
|---|
| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo HFA-MDI four times a day for 21 days. |
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| Secondary | Participant Responses: Percentage of Participants With a >=15% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22 | The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. This outcome counts participants who responded to therapy by obtaining a >+15% increase in PEF within 30 minutes of dose. The baseline PEF was defined as the average of the two test-day pre-dose baseline PEF values. | | Posted | | Number | | percentage of participants | | Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing | | | | ID | Title | Description |
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| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo HFA-MDI four times a day for 21 days. |
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| Secondary | Participant Responses: Percentage of Participants With a >=12% Increase in Baseline PEF Within 30 Minutes Post-Dose on Days 1 and 22 | The PEF test is conducted by having a person blow as hard as they can into a mouthpiece attached to a sensor that measures the rate of air blown. This outcome counts participants who responded to therapy by obtaining a >+12% increase in PEF within 30 minutes of dose. The baseline PEF was defined as the average of the two test-day pre-dose baseline PEF values. | | Posted | | Number | | percentage of participants | | Days 1 and 22: 35±5 and 10±2 min prior to dosing, and at 5±2, 15±5, 30±5 post dosing | | | | ID | Title | Description |
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| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo HFA-MDI four times a day for 21 days. |
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| Secondary | Weekly Average Highest (Worst) Daily Asthma Symptom Scores for Weeks 1, 2 and 3 | Highest daily asthma symptom scores by study week. For this assessment, patients self-evaluate and record on the diary card the following asthma symptoms experienced during the day (i.e. last 12-14 hours): wheeze, shortness of breath, cough, tightness of chest. The worst of these symptoms were scored daily on a four-point scale:
- 0 = No symptoms occurred
- 1 = Symptom occurred but did not interfere with daily activity
- 2 = Symptom occurred but was sometimes annoying or interfered with daily activity
- 3 = Symptom present even at rest and was annoying or interfered with daily activity
| | Posted | | Mean | Standard Error | units on a scale | | Weeks 1, 2, 3 | | | | ID | Title | Description |
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| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo HFA-MDI four times a day for 21 days. |
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| Secondary | The Number of Asthma-Related Nocturnal Awakenings Per Week Requiring the Use of Rescue Medication | Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night. | | Posted | | Mean | Standard Deviation | awakenings/week | | Run-in (Days -21 to -1), Weeks 1, 2, 3 | | | | ID | Title | Description |
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| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo HFA-MDI four times a day for 21 days. |
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| Secondary | Weekly Average Peak Expiratory Flow (PEF) Obtained Pre-Dose Each Morning | Participants measured their PEF as trained by taking as deep a breath as possible, placing their mouth firmly around the mouthpiece of the flow meter to form a tight seal, and exhaling as hard and as fast as possible. Subjects repeated the process twice at intervals of approximately 30 seconds, and then recorded the highest of the three PEF values on the diary card. | | Posted | | Mean | Standard Error | Liters/minute | | Weeks 1, 2, 3 | | | | ID | Title | Description |
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| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo HFA-MDI four times a day for 21 days. |
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| Secondary | Weekly Average Number of Puffs of Rescue Medication Taken Each Day for Study Weeks 1, 2 and 3 | Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night and the number of puffs of rescue albuterol used during the night after going to bed. At the end of each day, the number of puffs of albuterol rescue medication used during the day were recorded. | | Posted | | Mean | 95% Confidence Interval | Number of puffs per day | | Weeks 1, 2, 3 | | | | ID | Title | Description |
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| OG000 | Albuterol | Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. | | OG001 | Placebo | Placebo HFA-MDI four times a day for 21 days. |
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