| Primary | Mean Heart Rate | Heart rate measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes). | Intent to treat population | Posted | | Mean | Standard Deviation | beats per minute | | predose, various timeframes up to 5 hours post last dose | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
| | | Title | Denominators | Categories |
|---|
| Predose (n=51,52,40) | | | Title | Measurements |
|---|
| - OG00087.6± 12.56
- OG00184.7± 14.11
- OG00287.0± 17.47
|
| | 15 min post dose 1 (n=51,52,40) |
| |
| Secondary | Mean Forced Expiratory Volume in One Second(FEV1) | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. | Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses. | Posted | | Mean | Standard Deviation | liters | | predose, various postdose times | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
| |
| Primary | Change From Predose in Mean Heart Rate | Heart rate measured at various timepoints minus the heart rate at predose. | Intent to treat population | Posted | | Mean | Standard Deviation | beats per minute | | predose, various timeframes up to 5 hours post last dose | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
| |
| Primary | Mean Systolic Blood Pressure | Systolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes). | Intent to treat population | Posted | | Mean | Standard Deviation | mmHg | | predose, various timeframes up to 5 hours post last dose | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
| |
| Primary | Change From Predose in Mean Systolic Blood Pressure | Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose | Intent to treat population | Posted | | Mean | Standard Deviation | mmHg | | predose, various timeframes up to 5 hours post last dose | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
| |
| Primary | Mean Diastolic Blood Pressure | Diastolic blood pressure measured at various timepoints: predose and timepoints after each of the three dosings. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes). | Intent to treat population | Posted | | Mean | Standard Deviation | mmHg | | predose, various timeframes up to 5 hours post last dose | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
| |
| Primary | Change From Predose in Mean Diastolic Blood Pressure | Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure | Intent to treat population | Posted | | Mean | Standard Deviation | mmHg | | predose, various timeframes up to 5 hours post last dose | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
| |
| Primary | Mean Serum Potassium Levels | | Intent to treat population | Posted | | Mean | Standard Deviation | mEq/L | | Predose, 2 hours and 6 hours postdose 1 | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
| |
| Primary | Change From Predose in Mean Serum Potassium | Change in mean serum potassium at the specified timepoint minus the predose value. | Intent to treat population | Posted | | Mean | Standard Deviation | mEq/L | | predose, 2 and 6 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
| |
| Primary | Mean Serum Glucose Values | | Intent to treat population | Posted | | Mean | Standard Deviation | mg/dl | | Predose, 2 and 6 hours post dose 1 | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
| |
| Primary | Change From Predose in Mean Serum Glucose | Change in mean serum glucose at the specified timepoint minus the predose value. | Intent to treat population | Posted | | Mean | Standard Deviation | mg/dl | | predose, 2 and 6 hours post dose | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
| |
| Secondary | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. Change in FEV1 was calculated as postdose value minus the predose value at each visit. | Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses | Posted | | Mean | Standard Deviation | liters | | predose, various postdose timepoints | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
|
| Secondary | Mean Peak Expiratory Flow Rate (PEFR) | PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters. | Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses. | Posted | | Mean | Standard Deviation | liters/second | | predose, various postdose times | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
| |
| Secondary | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | PEFR is the fastest rate at which air can move through the airways during a forced expiration starting with fully inflated lungs as measured by peak flow meters. Change in PEFR was calculated as postdose value minus the predose value at each visit. | Intent to treat population. Pulmonary function testing was only performed on subjects six years of age or older; there were no subjects five or younger who performed spirometry. Subject data for those who were misdosed with ARF 7.5mcg rather than ARF 15mcg in the open-label portion were excluded from these analyses. | Posted | | Mean | Standard Deviation | liters/second | | predose, various postdose times | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
|
| Secondary | Plasma Concentration of (R,R) Formoterol | If the mean plasma concentration was 'below the limit of quantification' (BLQ) which was set as <=0.5 picograms/milliliter, the value is displayed as a zero. | PK population consisted of subjects who were in the intent-to-treat population and had any plasma concentration data available. | Posted | | Mean | Standard Deviation | picogram/milliliter | | predose, various postdose times | | | | ID | Title | Description |
|---|
| OG000 | Levalbuterol 0.63 mg | Values represent participant experience when treated with levalbuterol during the cross-over portion of the study | | OG001 | Arformoterol 7.5 Mcg | Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study | | OG002 | Arformoterol 15 Mcg | Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study |
| |