Asthma
Conditions
Keywords
Asthma, Respiratory Tract Diseases
Brief summary
To determine the safety and tolerability of Arformoterol Tartrate in children with asthma
Detailed description
A randomized, double-blind two-way crossover study of three cumulative doses of arformoterol (7.5 ug per nebulization) and levalbuterol (0.63 mg per nebulization) given over a one hour period, followed by a single open-label treatment day with three cumulative doses of arformoterol 15 ug in subjects 2-11 years of age with asthma. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Interventions
DRUGarformoterol
Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. 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).
DRUGlevalbuterol
Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. 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).
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Male and Female * Between Age 2 and 11, inclusive, at the time of consent * Weight equal to or greater than 15 Kg * History of physician-diagnosed asthma of at least 2 years duration for children age 6 and older, and at least 1 year duration for children 5 and younger.
Exclusion criteria
* Female subject who is pregnant or lactating. * Subject who has a history of hospitalization for asthma within one year, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial. * Subject with any history of life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures. * Subject with a history of cancer. * Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders. * Subject with a history of cigarette smoking or use of any tobacco products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Predose in Mean Serum Glucose | predose, 2 and 6 hours post dose | Change in mean serum glucose at the specified timepoint minus the predose value. |
| Mean Diastolic Blood Pressure | predose, various timeframes up to 5 hours post last dose | 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). |
| Change From Predose in Mean Diastolic Blood Pressure | predose, various timeframes up to 5 hours post last dose | Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure |
| Mean Serum Potassium Levels | Predose, 2 hours and 6 hours postdose 1 | — |
| Change From Predose in Mean Serum Potassium | predose, 2 and 6 hours post dose | Change in mean serum potassium at the specified timepoint minus the predose value. |
| Mean Serum Glucose Values | Predose, 2 and 6 hours post dose 1 | — |
| Mean Heart Rate | predose, various timeframes up to 5 hours post last dose | 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). |
| Change From Predose in Mean Heart Rate | predose, various timeframes up to 5 hours post last dose | Heart rate measured at various timepoints minus the heart rate at predose. |
| Mean Systolic Blood Pressure | predose, various timeframes up to 5 hours post last dose | 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). |
| Change From Predose in Mean Systolic Blood Pressure | predose, various timeframes up to 5 hours post last dose | Mean systolic blood pressure measured at various timepoints minus the mean systolic blood pressure at predose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | predose, various postdose timepoints | 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. |
| Mean Peak Expiratory Flow Rate (PEFR) | predose, various postdose times | 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 From Predose in Mean Peak Expiratory Flow Rate (PEFR) | predose, various postdose times | 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. |
| Plasma Concentration of (R,R) Formoterol | predose, various postdose times | 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. |
| Mean Forced Expiratory Volume in One Second(FEV1) | predose, various postdose times | Forced Expiratory Volume in one second (FEV1) is the volume of air forcibly exhaled in one second as measured by a spirometer. |
Countries
United States
Participant flow
Pre-assignment details
86 subjects were screened: 23 subjects aged 2-5 years and 63 subjects aged 6-11 years.
Participants by arm
| Arm | Count |
|---|---|
| ARF/LEV Cross-over: Participants treated with arformoterol 7.5 microgram per nebulization; 7 day washout; levalbuterol 0.63 milligram per nebulization.
Open label: 7 day washout; arformoterol 15 microgram per nebulization. | 27 |
| LEV/ARF Cross-over: Participants treated with levalbuterol 0.63 milligram per nebulization; 7 day washout; arformoterol 7.5 microgram per nebulization.
Open label: 7 day washout; arformoterol 15 microgram per nebulization. | 26 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Cross-over Period | Adverse Event | 2 | 0 |
| Cross-over Period | Did not meet-no longer met entry criteri | 0 | 1 |
| Cross-over Period | Other | 1 | 1 |
| Cross-over Period | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Total | LEV/ARF | ARF/LEV |
|---|---|---|---|
| Age, Categorical <=18 years | 53 Participants | 26 Participants | 27 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous Age 2-5 years | 4.4 years STANDARD_DEVIATION 0.76 | 4.4 years STANDARD_DEVIATION 0.79 | 4.4 years STANDARD_DEVIATION 0.79 |
| Age Continuous Age 6-11 years | 8.8 years STANDARD_DEVIATION 1.35 | 8.5 years STANDARD_DEVIATION 1.43 | 9.0 years STANDARD_DEVIATION 1.26 |
| Height | 131.03 centimeters STANDARD_DEVIATION 15.174 | 130.42 centimeters STANDARD_DEVIATION 15.377 | 131.62 centimeters STANDARD_DEVIATION 15.244 |
| Race/Ethnicity, Customized Black/African American | 20 participants | 14 participants | 6 participants |
| Race/Ethnicity, Customized Other | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized White/Caucasian | 31 participants | 12 participants | 19 participants |
| Region of Enrollment United States | 53 participants | 26 participants | 27 participants |
| Sex: Female, Male Female | 25 Participants | 12 Participants | 13 Participants |
| Sex: Female, Male Male | 28 Participants | 14 Participants | 14 Participants |
| Weight | 32.12 kilograms STANDARD_DEVIATION 12.345 | 32.68 kilograms STANDARD_DEVIATION 12.802 | 31.57 kilograms STANDARD_DEVIATION 12.106 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 51 | 7 / 52 | 8 / 40 |
| serious Total, serious adverse events | 0 / 51 | 0 / 52 | 0 / 40 |
Outcome results
Primary
Change From Predose in Mean Diastolic Blood Pressure
Mean diastolic blood pressure measured at various timepoints minus the predose diastolic blood pressure
Time frame: predose, various timeframes up to 5 hours post last dose
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 30 min post dose 2 (n=47,50,40) | 0.8 mmHg | Standard Deviation 7.82 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 30 min post dose 1 (n=51,52,40) | -1.7 mmHg | Standard Deviation 7.69 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 60 min post dose 1 (n=51,51,40) | 0.8 mmHg | Standard Deviation 7.89 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 15 min post dose 2 (n=50,51,40) | -1.1 mmHg | Standard Deviation 8.1 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 15 min post dose 1 (n=51,52,40) | -1.1 mmHg | Standard Deviation 8.6 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 60 min post dose 2 (n=46,50,37) | 0.0 mmHg | Standard Deviation 7.08 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 30 min post last dose (n=49,52,40) | 0.8 mmHg | Standard Deviation 7.12 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 60 min post last dose (n=49,52,40) | 0.8 mmHg | Standard Deviation 8.84 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 1.5 hours post last dose (n=48,52,40) | 0.1 mmHg | Standard Deviation 8 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 2 hours post last dose (n=50,52,40) | 1.4 mmHg | Standard Deviation 10.16 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 2.5 hours post last dose (n=49,52,40) | -1.9 mmHg | Standard Deviation 8.66 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 3 hours post last dose (n=50,52,40) | 0.8 mmHg | Standard Deviation 8.45 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 3.5 hours post last dose (n=50,52,40) | -0.4 mmHg | Standard Deviation 8.36 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 4 hours post last dose (n=50,52,40) | 0.5 mmHg | Standard Deviation 10.38 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 4.5 hours post last dose (n=50,52,40) | 0.2 mmHg | Standard Deviation 8.86 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Diastolic Blood Pressure | 5 hours post last dose (n=50,52,40) | -0.1 mmHg | Standard Deviation 8.84 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 60 min post dose 2 (n=46,50,37) | -1.3 mmHg | Standard Deviation 6.98 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 30 min post last dose (n=49,52,40) | -1.2 mmHg | Standard Deviation 7.34 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 60 min post last dose (n=49,52,40) | -1.1 mmHg | Standard Deviation 8.48 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 4 hours post last dose (n=50,52,40) | -0.0 mmHg | Standard Deviation 7.63 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 1.5 hours post last dose (n=48,52,40) | -0.9 mmHg | Standard Deviation 7.23 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 2 hours post last dose (n=50,52,40) | -0.9 mmHg | Standard Deviation 7.7 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 5 hours post last dose (n=50,52,40) | -0.1 mmHg | Standard Deviation 8.06 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 2.5 hours post last dose (n=49,52,40) | -3.5 mmHg | Standard Deviation 7.36 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 15 min post dose 1 (n=51,52,40) | -1.1 mmHg | Standard Deviation 7.26 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 4.5 hours post last dose (n=50,52,40) | -1.0 mmHg | Standard Deviation 7.64 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 30 min post dose 1 (n=51,52,40) | -0.6 mmHg | Standard Deviation 7.84 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 3 hours post last dose (n=50,52,40) | -1.8 mmHg | Standard Deviation 8.31 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 60 min post dose 1 (n=51,51,40) | -0.7 mmHg | Standard Deviation 7.71 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 15 min post dose 2 (n=50,51,40) | 0.1 mmHg | Standard Deviation 6.85 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 30 min post dose 2 (n=47,50,40) | -1.1 mmHg | Standard Deviation 7.59 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 3.5 hours post last dose (n=50,52,40) | -2.6 mmHg | Standard Deviation 6.66 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 2.5 hours post last dose (n=49,52,40) | -1.3 mmHg | Standard Deviation 9.56 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 60 min post dose 2 (n=46,50,37) | -1.8 mmHg | Standard Deviation 6.91 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 3.5 hours post last dose (n=50,52,40) | -1.0 mmHg | Standard Deviation 8.87 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 60 min post dose 1 (n=51,51,40) | -1.3 mmHg | Standard Deviation 9.43 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 30 min post last dose (n=49,52,40) | -1.9 mmHg | Standard Deviation 9.35 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 5 hours post last dose (n=50,52,40) | -3.6 mmHg | Standard Deviation 10.25 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 15 min post dose 1 (n=51,52,40) | -1.0 mmHg | Standard Deviation 10.23 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 60 min post last dose (n=49,52,40) | -1.1 mmHg | Standard Deviation 8.31 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 3 hours post last dose (n=50,52,40) | -1.1 mmHg | Standard Deviation 10.49 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 30 min post dose 2 (n=47,50,40) | -1.9 mmHg | Standard Deviation 9.59 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 1.5 hours post last dose (n=48,52,40) | -1.1 mmHg | Standard Deviation 9.38 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 4 hours post last dose (n=50,52,40) | -3.7 mmHg | Standard Deviation 10.29 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 30 min post dose 1 (n=51,52,40) | -1.9 mmHg | Standard Deviation 7.27 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 2 hours post last dose (n=50,52,40) | -1.5 mmHg | Standard Deviation 9.39 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 15 min post dose 2 (n=50,51,40) | -2.8 mmHg | Standard Deviation 9.65 |
| Arformoterol 15 Mcg | Change From Predose in Mean Diastolic Blood Pressure | 4.5 hours post last dose (n=50,52,40) | -1.7 mmHg | Standard Deviation 10.42 |
Primary
Change From Predose in Mean Heart Rate
Heart rate measured at various timepoints minus the heart rate at predose.
Time frame: predose, various timeframes up to 5 hours post last dose
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 2.5 hours post last dose (n=49,52,40) | 6.8 beats per minute | Standard Deviation 11.2 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 3 hours post last dose (n=50,52,40) | 6.7 beats per minute | Standard Deviation 10.94 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 30 min post dose 1 (n=51,52,40) | 3.2 beats per minute | Standard Deviation 11.91 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 3.5 hours post last dose (n=50,52,40) | 5.9 beats per minute | Standard Deviation 11.89 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 30 min post dose 2 (n=47,50,40) | 10.0 beats per minute | Standard Deviation 10.67 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 4.5 hours post last dose (n=50,52,40) | 5.9 beats per minute | Standard Deviation 10.86 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 5 hours post last dose (n=50,51,40) | 5.0 beats per minute | Standard Deviation 12.03 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 4 hours post last dose (n=50,52,40) | 6.6 beats per minute | Standard Deviation 10.3 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 60 min post dose 2 (n=46,50,37) | 13.2 beats per minute | Standard Deviation 13.81 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 30 min post last dose (n=49,52,40) | 11.9 beats per minute | Standard Deviation 14.11 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 60 min post dose 1 (n=51,51,40) | 8.7 beats per minute | Standard Deviation 10.7 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 60 min post last dose (n=49,52,40) | 8.7 beats per minute | Standard Deviation 13.97 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 1.5 hours post last dose (n=48,52,40) | 8.9 beats per minute | Standard Deviation 11.73 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 15 min post dose 1 (n=51,52,40) | 1.6 beats per minute | Standard Deviation 10.27 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 2 hours post last dose (n=50,52,40) | 5.6 beats per minute | Standard Deviation 12.13 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Heart Rate | 15 min post dose 2 (n=50,51,40) | 7.8 beats per minute | Standard Deviation 10.72 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 60 min post dose 1 (n=51,51,40) | 4.4 beats per minute | Standard Deviation 11.85 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 15 min post dose 2 (n=50,51,40) | 2.8 beats per minute | Standard Deviation 11.48 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 60 min post dose 2 (n=46,50,37) | 4.7 beats per minute | Standard Deviation 10.5 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 3 hours post last dose (n=50,52,40) | 5.9 beats per minute | Standard Deviation 12.74 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 15 min post dose 1 (n=51,52,40) | 0.5 beats per minute | Standard Deviation 9.4 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 2.5 hours post last dose (n=49,52,40) | 5.5 beats per minute | Standard Deviation 14.33 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 3.5 hours post last dose (n=50,52,40) | 5.1 beats per minute | Standard Deviation 11.63 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 30 min post last dose (n=49,52,40) | 5.6 beats per minute | Standard Deviation 11.44 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 4 hours post last dose (n=50,52,40) | 4.6 beats per minute | Standard Deviation 13.51 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 30 min post dose 2 (n=47,50,40) | 4.5 beats per minute | Standard Deviation 10.46 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 1.5 hours post last dose (n=48,52,40) | 7.1 beats per minute | Standard Deviation 12.65 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 4.5 hours post last dose (n=50,52,40) | 4.9 beats per minute | Standard Deviation 12 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 30 min post dose 1 (n=51,52,40) | 2.0 beats per minute | Standard Deviation 11.06 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 2 hours post last dose (n=50,52,40) | 6.6 beats per minute | Standard Deviation 10.77 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 5 hours post last dose (n=50,51,40) | 5.3 beats per minute | Standard Deviation 12.41 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Heart Rate | 60 min post last dose (n=49,52,40) | 8.6 beats per minute | Standard Deviation 14.06 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 5 hours post last dose (n=50,51,40) | 5.8 beats per minute | Standard Deviation 12.55 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 15 min post dose 1 (n=51,52,40) | 2.3 beats per minute | Standard Deviation 10.33 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 30 min post dose 1 (n=51,52,40) | 2.5 beats per minute | Standard Deviation 11.14 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 60 min post dose 1 (n=51,51,40) | 6.5 beats per minute | Standard Deviation 12.62 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 15 min post dose 2 (n=50,51,40) | 5.5 beats per minute | Standard Deviation 12.89 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 30 min post dose 2 (n=47,50,40) | 6.3 beats per minute | Standard Deviation 12.9 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 60 min post dose 2 (n=46,50,37) | 9.5 beats per minute | Standard Deviation 12.89 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 30 min post last dose (n=49,52,40) | 9.0 beats per minute | Standard Deviation 13.34 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 60 min post last dose (n=49,52,40) | 10.0 beats per minute | Standard Deviation 14.81 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 1.5 hours post last dose (n=48,52,40) | 8.3 beats per minute | Standard Deviation 15.95 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 2 hours post last dose (n=50,52,40) | 8.9 beats per minute | Standard Deviation 12.69 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 2.5 hours post last dose (n=49,52,40) | 7.8 beats per minute | Standard Deviation 13.36 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 3 hours post last dose (n=50,52,40) | 6.4 beats per minute | Standard Deviation 13.31 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 3.5 hours post last dose (n=50,52,40) | 7.9 beats per minute | Standard Deviation 12.11 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 4 hours post last dose (n=50,52,40) | 7.4 beats per minute | Standard Deviation 11.62 |
| Arformoterol 15 Mcg | Change From Predose in Mean Heart Rate | 4.5 hours post last dose (n=50,52,40) | 6.9 beats per minute | Standard Deviation 12.7 |
Primary
Change From Predose in Mean Serum Glucose
Change in mean serum glucose at the specified timepoint minus the predose value.
Time frame: predose, 2 and 6 hours post dose
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Change From Predose in Mean Serum Glucose | 2 hours post dose 1 (n=48,47,39) | 27.1 mg/dl | Standard Deviation 34.74 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Serum Glucose | 6 hours post dose 1 (n=49,48,38) | 20.3 mg/dl | Standard Deviation 22.49 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Serum Glucose | 2 hours post dose 1 (n=48,47,39) | 22.4 mg/dl | Standard Deviation 32.66 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Serum Glucose | 6 hours post dose 1 (n=49,48,38) | 12.1 mg/dl | Standard Deviation 20.59 |
| Arformoterol 15 Mcg | Change From Predose in Mean Serum Glucose | 2 hours post dose 1 (n=48,47,39) | 32.9 mg/dl | Standard Deviation 35.21 |
| Arformoterol 15 Mcg | Change From Predose in Mean Serum Glucose | 6 hours post dose 1 (n=49,48,38) | 18.6 mg/dl | Standard Deviation 23.11 |
Primary
Change From Predose in Mean Serum Potassium
Change in mean serum potassium at the specified timepoint minus the predose value.
Time frame: predose, 2 and 6 hours post dose
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Change From Predose in Mean Serum Potassium | 2 hours post dose 1 (n=48,47,38) | -0.58 mEq/L | Standard Deviation 0.457 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Serum Potassium | 6 hours post dose 1 (n=48,49,38) | -0.23 mEq/L | Standard Deviation 0.307 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Serum Potassium | 2 hours post dose 1 (n=48,47,38) | -0.42 mEq/L | Standard Deviation 0.407 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Serum Potassium | 6 hours post dose 1 (n=48,49,38) | -0.31 mEq/L | Standard Deviation 0.45 |
| Arformoterol 15 Mcg | Change From Predose in Mean Serum Potassium | 2 hours post dose 1 (n=48,47,38) | -0.62 mEq/L | Standard Deviation 0.401 |
| Arformoterol 15 Mcg | Change From Predose in Mean Serum Potassium | 6 hours post dose 1 (n=48,49,38) | -0.39 mEq/L | Standard Deviation 0.424 |
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
Time frame: predose, various timeframes up to 5 hours post last dose
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 30 min post dose 2 (n=47,50,40) | 3.3 mmHg | Standard Deviation 8.59 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 30 min post dose 1 (n=51,52,40) | 2.6 mmHg | Standard Deviation 10.14 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 60 min post dose 1 (n=51,51,40) | 3.7 mmHg | Standard Deviation 8.6 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 15 min post dose 2 (n=50,51,40) | 2.6 mmHg | Standard Deviation 8.94 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 15 min post dose 1 (n=51,52,40) | 0.8 mmHg | Standard Deviation 10.58 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 60 min post dose 2 (n=46,50,37) | 4.0 mmHg | Standard Deviation 7.89 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 30 min post last dose (n=49,52,40) | 2.4 mmHg | Standard Deviation 10.72 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 60 min post last dose (n=49,52,40) | 3.5 mmHg | Standard Deviation 10.92 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 1.5 hours post last dose (n=48,52,40) | 1.8 mmHg | Standard Deviation 9.7 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 2 hours post last dose (n=50,52,40) | 2.3 mmHg | Standard Deviation 10.31 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 2.5 hours post last dose (n=49,52,40) | 0.4 mmHg | Standard Deviation 10.12 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 3 hours post last dose (n=50,52,40) | 3.9 mmHg | Standard Deviation 10.58 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 3.5 hours post last dose (n=50,52,40) | 1.2 mmHg | Standard Deviation 8.87 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 4 hours post last dose (n=50,52,40) | 1.3 mmHg | Standard Deviation 11.08 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 4.5 hours post last dose (n=50,52,40) | 2.2 mmHg | Standard Deviation 10.37 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Systolic Blood Pressure | 5 hours post last dose (n=50,52,40) | 4.5 mmHg | Standard Deviation 10.79 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 60 min post dose 2 (n=46,50,37) | -0.3 mmHg | Standard Deviation 8.98 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 30 min post last dose (n=49,52,40) | -0.4 mmHg | Standard Deviation 9.37 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 60 min post last dose (n=49,52,40) | 1.5 mmHg | Standard Deviation 11.17 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 4 hours post last dose (n=50,52,40) | 0.6 mmHg | Standard Deviation 10.17 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 1.5 hours post last dose (n=48,52,40) | 0.3 mmHg | Standard Deviation 10.22 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 2 hours post last dose (n=50,52,40) | 1.8 mmHg | Standard Deviation 10.18 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 5 hours post last dose (n=50,52,40) | 2.5 mmHg | Standard Deviation 8.9 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 2.5 hours post last dose (n=49,52,40) | -0.0 mmHg | Standard Deviation 8.8 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 15 min post dose 1 (n=51,52,40) | -0.4 mmHg | Standard Deviation 9.57 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 4.5 hours post last dose (n=50,52,40) | 1.7 mmHg | Standard Deviation 9.61 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 30 min post dose 1 (n=51,52,40) | 0.9 mmHg | Standard Deviation 6.97 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 3 hours post last dose (n=50,52,40) | 0.6 mmHg | Standard Deviation 8.83 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 60 min post dose 1 (n=51,51,40) | 1.1 mmHg | Standard Deviation 9.54 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 15 min post dose 2 (n=50,51,40) | -0.3 mmHg | Standard Deviation 9.28 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 30 min post dose 2 (n=47,50,40) | 0.8 mmHg | Standard Deviation 9.01 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Systolic Blood Pressure | 3.5 hours post last dose (n=50,52,40) | 1.7 mmHg | Standard Deviation 10.18 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 2.5 hours post last dose (n=49,52,40) | 0.7 mmHg | Standard Deviation 7.77 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 60 min post dose 2 (n=46,50,37) | 1.8 mmHg | Standard Deviation 8.87 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 3.5 hours post last dose (n=50,52,40) | 0.9 mmHg | Standard Deviation 7.06 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 60 min post dose 1 (n=51,51,40) | 2.6 mmHg | Standard Deviation 7.97 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 30 min post last dose (n=49,52,40) | 1.1 mmHg | Standard Deviation 11.25 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 5 hours post last dose (n=50,52,40) | 1.6 mmHg | Standard Deviation 9.62 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 15 min post dose 1 (n=51,52,40) | 2.0 mmHg | Standard Deviation 8.06 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 60 min post last dose (n=49,52,40) | 4.4 mmHg | Standard Deviation 8.43 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 3 hours post last dose (n=50,52,40) | 1.3 mmHg | Standard Deviation 7.28 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 30 min post dose 2 (n=47,50,40) | 1.4 mmHg | Standard Deviation 7.19 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 1.5 hours post last dose (n=48,52,40) | 2.4 mmHg | Standard Deviation 8.06 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 4 hours post last dose (n=50,52,40) | -0.0 mmHg | Standard Deviation 8.36 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 30 min post dose 1 (n=51,52,40) | -0.3 mmHg | Standard Deviation 7.68 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 2 hours post last dose (n=50,52,40) | 1.3 mmHg | Standard Deviation 9.44 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 15 min post dose 2 (n=50,51,40) | 1.6 mmHg | Standard Deviation 9.07 |
| Arformoterol 15 Mcg | Change From Predose in Mean Systolic Blood Pressure | 4.5 hours post last dose (n=50,52,40) | 0.9 mmHg | Standard Deviation 8.26 |
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).
Time frame: predose, various timeframes up to 5 hours post last dose
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 15 min post dose 2 (n=50,51,40) | 61.7 mmHg | Standard Deviation 8.76 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 60 min post dose 2 (n=46,50,37) | 62.8 mmHg | Standard Deviation 8.07 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 3.5 hours post last dose (n=50,52,40) | 62.0 mmHg | Standard Deviation 9.8 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 30 min post dose 1 (n=51,52,40) | 60.8 mmHg | Standard Deviation 8.34 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 30 min post last dose (n=49,52,40) | 63.4 mmHg | Standard Deviation 7.27 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 4.5 hours post last dose (n=50,52,40) | 62.6 mmHg | Standard Deviation 9.12 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 3 hours post last dose (n=50,52,40) | 63.2 mmHg | Standard Deviation 8.85 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 60 min post last dose (n=49,52,40) | 63.5 mmHg | Standard Deviation 8.88 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 15 min post dose 1 (n=51,52,40) | 61.4 mmHg | Standard Deviation 9.32 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | Predose (n=51,52,40) | 62.5 mmHg | Standard Deviation 8.19 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 1.5 hours post last dose (n=48,52,40) | 63.1 mmHg | Standard Deviation 9.09 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 5 hours post last dose (n=50,52,40) | 62.3 mmHg | Standard Deviation 8.75 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 60 min post dose 1 (n=51,51,40) | 63.4 mmHg | Standard Deviation 7.72 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 2 hours post last dose (n=50,52,40) | 63.8 mmHg | Standard Deviation 10.79 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 4 hours post last dose (n=50,52,40) | 62.9 mmHg | Standard Deviation 10.15 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 30 min post dose 2 (n=47,50,40) | 63.1 mmHg | Standard Deviation 7.35 |
| Levalbuterol 0.63 mg | Mean Diastolic Blood Pressure | 2.5 hours post last dose (n=49,52,40) | 60.7 mmHg | Standard Deviation 10.41 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | Predose (n=51,52,40) | 63.2 mmHg | Standard Deviation 6.82 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 3 hours post last dose (n=50,52,40) | 61.4 mmHg | Standard Deviation 7.51 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 3.5 hours post last dose (n=50,52,40) | 60.5 mmHg | Standard Deviation 6.54 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 15 min post dose 2 (n=50,51,40) | 63.3 mmHg | Standard Deviation 6.75 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 4 hours post last dose (n=50,52,40) | 63.1 mmHg | Standard Deviation 7.32 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 15 min post dose 1 (n=51,52,40) | 62.0 mmHg | Standard Deviation 7.29 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 4.5 hours post last dose (n=50,52,40) | 62.2 mmHg | Standard Deviation 7.84 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 30 min post dose 2 (n=47,50,40) | 62.2 mmHg | Standard Deviation 7.61 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 5 hours post last dose (n=50,52,40) | 63.0 mmHg | Standard Deviation 7.4 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 2.5 hours post last dose (n=49,52,40) | 59.7 mmHg | Standard Deviation 7.97 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 60 min post dose 2 (n=46,50,37) | 62.0 mmHg | Standard Deviation 8.15 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 30 min post last dose (n=49,52,40) | 62.0 mmHg | Standard Deviation 8.83 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 30 min post dose 1 (n=51,52,40) | 62.5 mmHg | Standard Deviation 7.61 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 60 min post last dose (n=49,52,40) | 62.1 mmHg | Standard Deviation 8.6 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 1.5 hours post last dose (n=48,52,40) | 62.3 mmHg | Standard Deviation 7.9 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 2 hours post last dose (n=50,52,40) | 62.3 mmHg | Standard Deviation 6.87 |
| Arformoterol 7.5 Mcg | Mean Diastolic Blood Pressure | 60 min post dose 1 (n=51,51,40) | 62.5 mmHg | Standard Deviation 7.47 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 5 hours post last dose (n=50,52,40) | 60.0 mmHg | Standard Deviation 8.59 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | Predose (n=51,52,40) | 63.6 mmHg | Standard Deviation 9.77 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 15 min post dose 1 (n=51,52,40) | 62.5 mmHg | Standard Deviation 8.52 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 30 min post dose 1 (n=51,52,40) | 61.6 mmHg | Standard Deviation 7.56 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 60 min post dose 1 (n=51,51,40) | 62.3 mmHg | Standard Deviation 9.38 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 15 min post dose 2 (n=50,51,40) | 60.8 mmHg | Standard Deviation 8.81 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 30 min post dose 2 (n=47,50,40) | 61.7 mmHg | Standard Deviation 8.86 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 60 min post dose 2 (n=46,50,37) | 62.3 mmHg | Standard Deviation 7.99 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 30 min post last dose (n=49,52,40) | 61.6 mmHg | Standard Deviation 7.91 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 60 min post last dose (n=49,52,40) | 62.5 mmHg | Standard Deviation 8.09 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 1.5 hours post last dose (n=48,52,40) | 62.5 mmHg | Standard Deviation 9.03 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 2 hours post last dose (n=50,52,40) | 62.1 mmHg | Standard Deviation 9.62 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 2.5 hours post last dose (n=49,52,40) | 62.3 mmHg | Standard Deviation 8.71 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 3 hours post last dose (n=50,52,40) | 62.5 mmHg | Standard Deviation 9.77 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 3.5 hours post last dose (n=50,52,40) | 62.6 mmHg | Standard Deviation 7.59 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 4 hours post last dose (n=50,52,40) | 59.9 mmHg | Standard Deviation 8.65 |
| Arformoterol 15 Mcg | Mean Diastolic Blood Pressure | 4.5 hours post last dose (n=50,52,40) | 61.9 mmHg | Standard Deviation 8.38 |
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).
Time frame: predose, various timeframes up to 5 hours post last dose
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Mean Heart Rate | 2.5 hours post last dose (n=49,52,40) | 94.1 beats per minute | Standard Deviation 16.22 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 60 min post dose 2 (n=46,50,37) | 100.4 beats per minute | Standard Deviation 16.6 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 15 min post dose 1 (n=51,52,40) | 89.3 beats per minute | Standard Deviation 15.57 |
| Levalbuterol 0.63 mg | Mean Heart Rate | Predose (n=51,52,40) | 87.6 beats per minute | Standard Deviation 12.56 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 30 min post last dose (n=49,52,40) | 99.2 beats per minute | Standard Deviation 17.38 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 4 hours post last dose (n=50,52,40) | 94.0 beats per minute | Standard Deviation 12.68 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 2 hours post last dose (n=50,52,40) | 93.0 beats per minute | Standard Deviation 16.23 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 60 min post last dose (n=49,52,40) | 96.0 beats per minute | Standard Deviation 16.45 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 60 min post dose 1 (n=51,51,40) | 96.4 beats per minute | Standard Deviation 12.33 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 1.5 hours post last dose (n=48,52,40) | 96.2 beats per minute | Standard Deviation 17.29 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 5 hours post last dose (n=50,51,40) | 92.4 beats per minute | Standard Deviation 15.36 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 3.5 hours post last dose (n=50,52,40) | 93.3 beats per minute | Standard Deviation 14.65 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 15 min post dose 2 (n=50,51,40) | 95.4 beats per minute | Standard Deviation 12.94 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 4.5 hours post last dose (n=50,52,40) | 93.3 beats per minute | Standard Deviation 13.71 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 3 hours post last dose (n=50,52,40) | 94.1 beats per minute | Standard Deviation 14.84 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 30 min post dose 2 (n=47,50,40) | 97.1 beats per minute | Standard Deviation 13.28 |
| Levalbuterol 0.63 mg | Mean Heart Rate | 30 min post dose 1 (n=51,52,40) | 90.9 beats per minute | Standard Deviation 14.47 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 2 hours post last dose (n=50,52,40) | 91.2 beats per minute | Standard Deviation 11.77 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | Predose (n=51,52,40) | 84.7 beats per minute | Standard Deviation 14.11 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 15 min post dose 1 (n=51,52,40) | 85.2 beats per minute | Standard Deviation 15.19 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 30 min post dose 1 (n=51,52,40) | 86.6 beats per minute | Standard Deviation 14.63 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 60 min post dose 1 (n=51,51,40) | 89.0 beats per minute | Standard Deviation 13.67 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 15 min post dose 2 (n=50,51,40) | 87.5 beats per minute | Standard Deviation 14.88 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 30 min post dose 2 (n=47,50,40) | 88.9 beats per minute | Standard Deviation 13.33 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 60 min post dose 2 (n=46,50,37) | 89.3 beats per minute | Standard Deviation 13.97 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 30 min post last dose (n=49,52,40) | 90.3 beats per minute | Standard Deviation 14.24 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 60 min post last dose (n=49,52,40) | 93.3 beats per minute | Standard Deviation 13.06 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 1.5 hours post last dose (n=48,52,40) | 91.8 beats per minute | Standard Deviation 11.75 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 2.5 hours post last dose (n=49,52,40) | 90.2 beats per minute | Standard Deviation 14.61 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 3 hours post last dose (n=50,52,40) | 90.6 beats per minute | Standard Deviation 13.57 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 3.5 hours post last dose (n=50,52,40) | 89.8 beats per minute | Standard Deviation 13.2 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 4 hours post last dose (n=50,52,40) | 89.3 beats per minute | Standard Deviation 11.76 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 4.5 hours post last dose (n=50,52,40) | 89.6 beats per minute | Standard Deviation 12.5 |
| Arformoterol 7.5 Mcg | Mean Heart Rate | 5 hours post last dose (n=50,51,40) | 89.8 beats per minute | Standard Deviation 14.16 |
| Arformoterol 15 Mcg | Mean Heart Rate | 15 min post dose 1 (n=51,52,40) | 89.4 beats per minute | Standard Deviation 16.88 |
| Arformoterol 15 Mcg | Mean Heart Rate | 2.5 hours post last dose (n=49,52,40) | 94.8 beats per minute | Standard Deviation 15.66 |
| Arformoterol 15 Mcg | Mean Heart Rate | 15 min post dose 2 (n=50,51,40) | 92.5 beats per minute | Standard Deviation 18.6 |
| Arformoterol 15 Mcg | Mean Heart Rate | 5 hours post last dose (n=50,51,40) | 92.9 beats per minute | Standard Deviation 14.51 |
| Arformoterol 15 Mcg | Mean Heart Rate | 3 hours post last dose (n=50,52,40) | 93.4 beats per minute | Standard Deviation 16.04 |
| Arformoterol 15 Mcg | Mean Heart Rate | 60 min post dose 1 (n=51,51,40) | 93.5 beats per minute | Standard Deviation 16.41 |
| Arformoterol 15 Mcg | Mean Heart Rate | 4.5 hours post last dose (n=50,52,40) | 93.9 beats per minute | Standard Deviation 16.49 |
| Arformoterol 15 Mcg | Mean Heart Rate | 3.5 hours post last dose (n=50,52,40) | 95.0 beats per minute | Standard Deviation 15.16 |
| Arformoterol 15 Mcg | Mean Heart Rate | 30 min post dose 1 (n=51,52,40) | 89.5 beats per minute | Standard Deviation 15.59 |
| Arformoterol 15 Mcg | Mean Heart Rate | Predose (n=51,52,40) | 87.0 beats per minute | Standard Deviation 17.47 |
| Arformoterol 15 Mcg | Mean Heart Rate | 60 min post last dose (n=49,52,40) | 97.1 beats per minute | Standard Deviation 14.95 |
| Arformoterol 15 Mcg | Mean Heart Rate | 4 hours post last dose (n=50,52,40) | 94.5 beats per minute | Standard Deviation 14.94 |
| Arformoterol 15 Mcg | Mean Heart Rate | 1.5 hours post last dose (n=48,52,40) | 95.3 beats per minute | Standard Deviation 16.42 |
| Arformoterol 15 Mcg | Mean Heart Rate | 30 min post last dose (n=49,52,40) | 96.1 beats per minute | Standard Deviation 13.92 |
| Arformoterol 15 Mcg | Mean Heart Rate | 60 min post dose 2 (n=46,50,37) | 96.1 beats per minute | Standard Deviation 12.8 |
| Arformoterol 15 Mcg | Mean Heart Rate | 2 hours post last dose (n=50,52,40) | 95.9 beats per minute | Standard Deviation 14.57 |
| Arformoterol 15 Mcg | Mean Heart Rate | 30 min post dose 2 (n=47,50,40) | 93.3 beats per minute | Standard Deviation 16.72 |
Primary
Mean Serum Glucose Values
Time frame: Predose, 2 and 6 hours post dose 1
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Mean Serum Glucose Values | 2 hours post dose 1 (n=48,47,39) | 114.5 mg/dl | Standard Deviation 30.42 |
| Levalbuterol 0.63 mg | Mean Serum Glucose Values | Predose (n=51,52,40) | 86.4 mg/dl | Standard Deviation 15.59 |
| Levalbuterol 0.63 mg | Mean Serum Glucose Values | 6 hours post dose 1 (n=49,48,38) | 107.6 mg/dl | Standard Deviation 18.43 |
| Arformoterol 7.5 Mcg | Mean Serum Glucose Values | 2 hours post dose 1 (n=48,47,39) | 108.6 mg/dl | Standard Deviation 27.51 |
| Arformoterol 7.5 Mcg | Mean Serum Glucose Values | Predose (n=51,52,40) | 87.5 mg/dl | Standard Deviation 15.43 |
| Arformoterol 7.5 Mcg | Mean Serum Glucose Values | 6 hours post dose 1 (n=49,48,38) | 99.0 mg/dl | Standard Deviation 15.78 |
| Arformoterol 15 Mcg | Mean Serum Glucose Values | Predose (n=51,52,40) | 87.6 mg/dl | Standard Deviation 17.41 |
| Arformoterol 15 Mcg | Mean Serum Glucose Values | 6 hours post dose 1 (n=49,48,38) | 106.3 mg/dl | Standard Deviation 15.64 |
| Arformoterol 15 Mcg | Mean Serum Glucose Values | 2 hours post dose 1 (n=48,47,39) | 120.6 mg/dl | Standard Deviation 32.52 |
Primary
Mean Serum Potassium Levels
Time frame: Predose, 2 hours and 6 hours postdose 1
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Mean Serum Potassium Levels | 2 hours post dose 1 (n=48,47,38) | 3.67 mEq/L | Standard Deviation 0.423 |
| Levalbuterol 0.63 mg | Mean Serum Potassium Levels | Predose (n=51,52,39) | 4.25 mEq/L | Standard Deviation 0.376 |
| Levalbuterol 0.63 mg | Mean Serum Potassium Levels | 6 hours post dose 1 (n=48,49,38) | 3.99 mEq/L | Standard Deviation 0.334 |
| Arformoterol 7.5 Mcg | Mean Serum Potassium Levels | 2 hours post dose 1 (n=48,47,38) | 3.83 mEq/L | Standard Deviation 0.391 |
| Arformoterol 7.5 Mcg | Mean Serum Potassium Levels | Predose (n=51,52,39) | 4.27 mEq/L | Standard Deviation 0.386 |
| Arformoterol 7.5 Mcg | Mean Serum Potassium Levels | 6 hours post dose 1 (n=48,49,38) | 3.95 mEq/L | Standard Deviation 0.325 |
| Arformoterol 15 Mcg | Mean Serum Potassium Levels | Predose (n=51,52,39) | 4.31 mEq/L | Standard Deviation 0.325 |
| Arformoterol 15 Mcg | Mean Serum Potassium Levels | 6 hours post dose 1 (n=48,49,38) | 3.87 mEq/L | Standard Deviation 0.435 |
| Arformoterol 15 Mcg | Mean Serum Potassium Levels | 2 hours post dose 1 (n=48,47,38) | 3.71 mEq/L | Standard Deviation 0.41 |
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).
Time frame: predose, various timeframes up to 5 hours post last dose
Population: Intent to treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 2.5 hours post last dose (n=49,52,40) | 103.0 mmHg | Standard Deviation 12.41 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 60 min post dose 2 (n=46,50,37) | 107.2 mmHg | Standard Deviation 12.05 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 15 min post dose 1 (n=51,52,40) | 102.9 mmHg | Standard Deviation 10.9 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | Predose (n=51,52,40) | 102.1 mmHg | Standard Deviation 10.8 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 30 min post last dose (n=49,52,40) | 105.0 mmHg | Standard Deviation 12.22 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 4 hours post last dose (n=50,52,40) | 103.6 mmHg | Standard Deviation 11.26 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 2 hours post last dose (n=50,52,40) | 104.6 mmHg | Standard Deviation 11.4 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 60 min post last dose (n=49,52,40) | 106.1 mmHg | Standard Deviation 10.32 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 60 min post dose 1 (n=51,51,40) | 105.8 mmHg | Standard Deviation 9.31 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 1.5 hours post last dose (n=48,52,40) | 104.8 mmHg | Standard Deviation 11.43 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 5 hours post last dose (n=50,52,40) | 106.7 mmHg | Standard Deviation 9.94 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 3.5 hours post last dose (n=50,52,40) | 103.4 mmHg | Standard Deviation 10 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 15 min post dose 2 (n=50,51,40) | 105.0 mmHg | Standard Deviation 11.2 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 4.5 hours post last dose (n=50,52,40) | 104.5 mmHg | Standard Deviation 10.5 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 3 hours post last dose (n=50,52,40) | 106.1 mmHg | Standard Deviation 12.28 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 30 min post dose 2 (n=47,50,40) | 106.4 mmHg | Standard Deviation 10.32 |
| Levalbuterol 0.63 mg | Mean Systolic Blood Pressure | 30 min post dose 1 (n=51,52,40) | 104.6 mmHg | Standard Deviation 12.08 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 2 hours post last dose (n=50,52,40) | 103.4 mmHg | Standard Deviation 10.81 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | Predose (n=51,52,40) | 101.5 mmHg | Standard Deviation 9.86 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 15 min post dose 1 (n=51,52,40) | 101.2 mmHg | Standard Deviation 11.07 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 30 min post dose 1 (n=51,52,40) | 102.5 mmHg | Standard Deviation 10.2 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 60 min post dose 1 (n=51,51,40) | 102.7 mmHg | Standard Deviation 9.82 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 15 min post dose 2 (n=50,51,40) | 101.7 mmHg | Standard Deviation 9.42 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 30 min post dose 2 (n=47,50,40) | 102.8 mmHg | Standard Deviation 9.26 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 60 min post dose 2 (n=46,50,37) | 101.9 mmHg | Standard Deviation 11.18 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 30 min post last dose (n=49,52,40) | 101.2 mmHg | Standard Deviation 11.72 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 60 min post last dose (n=49,52,40) | 103.0 mmHg | Standard Deviation 11.87 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 1.5 hours post last dose (n=48,52,40) | 101.9 mmHg | Standard Deviation 11.67 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 2.5 hours post last dose (n=49,52,40) | 101.5 mmHg | Standard Deviation 10.58 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 3 hours post last dose (n=50,52,40) | 102.1 mmHg | Standard Deviation 10.84 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 3.5 hours post last dose (n=50,52,40) | 103.2 mmHg | Standard Deviation 11.38 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 4 hours post last dose (n=50,52,40) | 102.1 mmHg | Standard Deviation 10.14 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 4.5 hours post last dose (n=50,52,40) | 103.2 mmHg | Standard Deviation 10.96 |
| Arformoterol 7.5 Mcg | Mean Systolic Blood Pressure | 5 hours post last dose (n=50,52,40) | 104.1 mmHg | Standard Deviation 10.46 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 15 min post dose 1 (n=51,52,40) | 102.6 mmHg | Standard Deviation 11.42 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 2.5 hours post last dose (n=49,52,40) | 101.3 mmHg | Standard Deviation 10.1 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 15 min post dose 2 (n=50,51,40) | 102.1 mmHg | Standard Deviation 12.2 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 5 hours post last dose (n=50,52,40) | 102.1 mmHg | Standard Deviation 9.49 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 3 hours post last dose (n=50,52,40) | 101.9 mmHg | Standard Deviation 11.57 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 60 min post dose 1 (n=51,51,40) | 103.2 mmHg | Standard Deviation 10.82 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 4.5 hours post last dose (n=50,52,40) | 101.5 mmHg | Standard Deviation 9.25 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 3.5 hours post last dose (n=50,52,40) | 101.4 mmHg | Standard Deviation 9.41 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 30 min post dose 1 (n=51,52,40) | 100.3 mmHg | Standard Deviation 9.78 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | Predose (n=51,52,40) | 100.6 mmHg | Standard Deviation 10.36 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 60 min post last dose (n=49,52,40) | 104.9 mmHg | Standard Deviation 11.03 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 4 hours post last dose (n=50,52,40) | 100.5 mmHg | Standard Deviation 10.48 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 1.5 hours post last dose (n=48,52,40) | 103.0 mmHg | Standard Deviation 10.35 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 30 min post last dose (n=49,52,40) | 101.6 mmHg | Standard Deviation 12.6 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 60 min post dose 2 (n=46,50,37) | 102.9 mmHg | Standard Deviation 9.95 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 2 hours post last dose (n=50,52,40) | 101.8 mmHg | Standard Deviation 10.87 |
| Arformoterol 15 Mcg | Mean Systolic Blood Pressure | 30 min post dose 2 (n=47,50,40) | 101.9 mmHg | Standard Deviation 9.81 |
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.
Time frame: predose, various postdose times
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 2 (n=36,38,27) | 0.452 liters/second | Standard Deviation 0.329 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 6 hours post dose 1 (n=36,38,27) | 0.324 liters/second | Standard Deviation 0.337 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 3 (n=35,38,26) | 0.539 liters/second | Standard Deviation 0.375 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 3 (n=34,38,27) | 0.524 liters/second | Standard Deviation 0.343 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 1 (n=37,38,27) | 0.322 liters/second | Standard Deviation 0.305 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 4 hours post dose 1 (n=36,38,27) | 0.509 liters/second | Standard Deviation 0.345 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 2 (n=36,38,27) | 0.458 liters/second | Standard Deviation 0.363 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 1 (n=37,37,27) | 0.399 liters/second | Standard Deviation 0.367 |
| Levalbuterol 0.63 mg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 2 hours post dose 1 (n=36,37,27) | 0.575 liters/second | Standard Deviation 0.385 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 3 (n=34,38,27) | 0.457 liters/second | Standard Deviation 0.439 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 1 (n=37,38,27) | 0.242 liters/second | Standard Deviation 0.298 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 1 (n=37,37,27) | 0.320 liters/second | Standard Deviation 0.392 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 2 (n=36,38,27) | 0.344 liters/second | Standard Deviation 0.369 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 2 (n=36,38,27) | 0.419 liters/second | Standard Deviation 0.363 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 3 (n=35,38,26) | 0.462 liters/second | Standard Deviation 0.429 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 2 hours post dose 1 (n=36,37,27) | 0.596 liters/second | Standard Deviation 0.596 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 4 hours post dose 1 (n=36,38,27) | 0.484 liters/second | Standard Deviation 0.44 |
| Arformoterol 7.5 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 6 hours post dose 1 (n=36,38,27) | 0.513 liters/second | Standard Deviation 0.72 |
| Arformoterol 15 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 2 (n=36,38,27) | 0.360 liters/second | Standard Deviation 0.406 |
| Arformoterol 15 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 1 (n=37,38,27) | 0.259 liters/second | Standard Deviation 0.396 |
| Arformoterol 15 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 2 hours post dose 1 (n=36,37,27) | 0.501 liters/second | Standard Deviation 0.408 |
| Arformoterol 15 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 1 (n=37,37,27) | 0.279 liters/second | Standard Deviation 0.442 |
| Arformoterol 15 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 6 hours post dose 1 (n=36,38,27) | 0.451 liters/second | Standard Deviation 0.462 |
| Arformoterol 15 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 3 (n=34,38,27) | 0.513 liters/second | Standard Deviation 0.466 |
| Arformoterol 15 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 2 (n=36,38,27) | 0.424 liters/second | Standard Deviation 0.383 |
| Arformoterol 15 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 4 hours post dose 1 (n=36,38,27) | 0.474 liters/second | Standard Deviation 0.449 |
| Arformoterol 15 Mcg | Change From Predose in Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 3 (n=35,38,26) | 0.449 liters/second | Standard Deviation 0.497 |
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.
Time frame: predose, various postdose timepoints
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 25 minutes post dose 2 (n=36,38,27) | 0.194 liters | Standard Deviation 0.153 |
| Levalbuterol 0.63 mg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 6 hours post dose 1 (n=36,38,27) | 0.098 liters | Standard Deviation 0.128 |
| Levalbuterol 0.63 mg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 25 minutes post dose 3 (n=35,38,26) | 0.226 liters | Standard Deviation 0.154 |
| Levalbuterol 0.63 mg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 10 minutes post dose 3 (n=34,38,27) | 0.226 liters | Standard Deviation 0.144 |
| Levalbuterol 0.63 mg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 10 minutes post dose 1 (n=37,38,27) | 0.160 liters | Standard Deviation 0.102 |
| Levalbuterol 0.63 mg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 4 hours post dose 1 (n=36,38,27) | 0.163 liters | Standard Deviation 0.15 |
| Levalbuterol 0.63 mg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 10 minutes post dose 2 (n=36,38,27) | 0.199 liters | Standard Deviation 0.13 |
| Levalbuterol 0.63 mg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 25 minutes post dose 1 (n=37,37,27) | 0.159 liters | Standard Deviation 0.139 |
| Levalbuterol 0.63 mg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 2 hours post dose 1 (n=36,37,27) | 0.216 liters | Standard Deviation 0.139 |
| Arformoterol 7.5 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 10 minutes post dose 3 (n=34,38,27) | 0.179 liters | Standard Deviation 0.16 |
| Arformoterol 7.5 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 10 minutes post dose 1 (n=37,38,27) | 0.117 liters | Standard Deviation 0.112 |
| Arformoterol 7.5 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 25 minutes post dose 1 (n=37,37,27) | 0.142 liters | Standard Deviation 0.151 |
| Arformoterol 7.5 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 10 minutes post dose 2 (n=36,38,27) | 0.169 liters | Standard Deviation 0.154 |
| Arformoterol 7.5 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 25 minutes post dose 2 (n=36,38,27) | 0.162 liters | Standard Deviation 0.166 |
| Arformoterol 7.5 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 25 minutes post dose 3 (n=35,38,26) | 0.188 liters | Standard Deviation 0.15 |
| Arformoterol 7.5 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 2 hours post dose 1 (n=36,37,27) | 0.194 liters | Standard Deviation 0.146 |
| Arformoterol 7.5 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 4 hours post dose 1 (n=36,38,27) | 0.170 liters | Standard Deviation 0.175 |
| Arformoterol 7.5 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 6 hours post dose 1 (n=36,38,27) | 0.173 liters | Standard Deviation 0.165 |
| Arformoterol 15 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 10 minutes post dose 2 (n=36,38,27) | 0.175 liters | Standard Deviation 0.106 |
| Arformoterol 15 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 10 minutes post dose 1 (n=37,38,27) | 0.133 liters | Standard Deviation 0.105 |
| Arformoterol 15 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 2 hours post dose 1 (n=36,37,27) | 0.218 liters | Standard Deviation 0.149 |
| Arformoterol 15 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 25 minutes post dose 1 (n=37,37,27) | 0.158 liters | Standard Deviation 0.125 |
| Arformoterol 15 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 6 hours post dose 1 (n=36,38,27) | 0.174 liters | Standard Deviation 0.166 |
| Arformoterol 15 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 10 minutes post dose 3 (n=34,38,27) | 0.203 liters | Standard Deviation 0.148 |
| Arformoterol 15 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 25 minutes post dose 2 (n=36,38,27) | 0.183 liters | Standard Deviation 0.137 |
| Arformoterol 15 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 4 hours post dose 1 (n=36,38,27) | 0.198 liters | Standard Deviation 0.15 |
| Arformoterol 15 Mcg | Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1) | 25 minutes post dose 3 (n=35,38,26) | 0.205 liters | Standard Deviation 0.152 |
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.
Time frame: predose, various postdose times
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Mean Forced Expiratory Volume in One Second(FEV1) | predose (n=37,38,27) | 1.554 liters | Standard Deviation 0.374 |
| Levalbuterol 0.63 mg | Mean Forced Expiratory Volume in One Second(FEV1) | 10 minutes post dose 1 (n=37,38,27) | 1.714 liters | Standard Deviation 0.411 |
| Levalbuterol 0.63 mg | Mean Forced Expiratory Volume in One Second(FEV1) | 25 minutes post dose 1 (n=37,37,27) | 1.712 liters | Standard Deviation 0.425 |
| Levalbuterol 0.63 mg | Mean Forced Expiratory Volume in One Second(FEV1) | 10 minutes post dose 2 (n=36,38,27) | 1.741 liters | Standard Deviation 0.43 |
| Levalbuterol 0.63 mg | Mean Forced Expiratory Volume in One Second(FEV1) | 25 minutes post dose 2 (n=36,38,27) | 1.735 liters | Standard Deviation 0.438 |
| Levalbuterol 0.63 mg | Mean Forced Expiratory Volume in One Second(FEV1) | 10 minutes post dose 3 (n=34,38,27) | 1.775 liters | Standard Deviation 0.402 |
| Levalbuterol 0.63 mg | Mean Forced Expiratory Volume in One Second(FEV1) | 25 minutes post dose 3 (n=35,38,26) | 1.782 liters | Standard Deviation 0.415 |
| Levalbuterol 0.63 mg | Mean Forced Expiratory Volume in One Second(FEV1) | 2 hours post dose 1 (n=36,37,27) | 1.784 liters | Standard Deviation 0.397 |
| Levalbuterol 0.63 mg | Mean Forced Expiratory Volume in One Second(FEV1) | 4 hours post dose 1 (n=36,38,27) | 1.732 liters | Standard Deviation 0.401 |
| Levalbuterol 0.63 mg | Mean Forced Expiratory Volume in One Second(FEV1) | 6 hours post dose 1 (n=36,38,27) | 1.667 liters | Standard Deviation 0.4 |
| Arformoterol 7.5 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 4 hours post dose 1 (n=36,38,27) | 1.722 liters | Standard Deviation 0.423 |
| Arformoterol 7.5 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | predose (n=37,38,27) | 1.552 liters | Standard Deviation 0.377 |
| Arformoterol 7.5 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 10 minutes post dose 3 (n=34,38,27) | 1.731 liters | Standard Deviation 0.419 |
| Arformoterol 7.5 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 25 minutes post dose 2 (n=36,38,27) | 1.714 liters | Standard Deviation 0.423 |
| Arformoterol 7.5 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 10 minutes post dose 1 (n=37,38,27) | 1.668 liters | Standard Deviation 0.403 |
| Arformoterol 7.5 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 6 hours post dose 1 (n=36,38,27) | 1.725 liters | Standard Deviation 0.426 |
| Arformoterol 7.5 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 2 hours post dose 1 (n=36,37,27) | 1.754 liters | Standard Deviation 0.408 |
| Arformoterol 7.5 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 25 minutes post dose 1 (n=37,37,27) | 1.695 liters | Standard Deviation 0.409 |
| Arformoterol 7.5 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 25 minutes post dose 3 (n=35,38,26) | 1.740 liters | Standard Deviation 0.419 |
| Arformoterol 7.5 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 10 minutes post dose 2 (n=36,38,27) | 1.721 liters | Standard Deviation 0.42 |
| Arformoterol 15 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 2 hours post dose 1 (n=36,37,27) | 1.704 liters | Standard Deviation 0.337 |
| Arformoterol 15 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 10 minutes post dose 2 (n=36,38,27) | 1.661 liters | Standard Deviation 0.332 |
| Arformoterol 15 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 25 minutes post dose 2 (n=36,38,27) | 1.669 liters | Standard Deviation 0.331 |
| Arformoterol 15 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 10 minutes post dose 3 (n=34,38,27) | 1.689 liters | Standard Deviation 0.34 |
| Arformoterol 15 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 4 hours post dose 1 (n=36,38,27) | 1.684 liters | Standard Deviation 0.344 |
| Arformoterol 15 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 25 minutes post dose 3 (n=35,38,26) | 1.700 liters | Standard Deviation 0.345 |
| Arformoterol 15 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | predose (n=37,38,27) | 1.486 liters | Standard Deviation 0.294 |
| Arformoterol 15 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 6 hours post dose 1 (n=36,38,27) | 1.660 liters | Standard Deviation 0.356 |
| Arformoterol 15 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 10 minutes post dose 1 (n=37,38,27) | 1.620 liters | Standard Deviation 0.315 |
| Arformoterol 15 Mcg | Mean Forced Expiratory Volume in One Second(FEV1) | 25 minutes post dose 1 (n=37,37,27) | 1.644 liters | Standard Deviation 0.334 |
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.
Time frame: predose, various postdose times
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Mean Peak Expiratory Flow Rate (PEFR) | predose (n=37,38,27) | 3.604 liters/second | Standard Deviation 0.949 |
| Levalbuterol 0.63 mg | Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 1 (n=37,38,27) | 3.926 liters/second | Standard Deviation 0.9 |
| Levalbuterol 0.63 mg | Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 1 (n=37,37,27) | 4.003 liters/second | Standard Deviation 0.893 |
| Levalbuterol 0.63 mg | Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 2 (n=36,38,27) | 4.053 liters/second | Standard Deviation 1.007 |
| Levalbuterol 0.63 mg | Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 2 (n=36,38,27) | 4.047 liters/second | Standard Deviation 0.982 |
| Levalbuterol 0.63 mg | Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 3 (n=34,38,27) | 4.156 liters/second | Standard Deviation 0.96 |
| Levalbuterol 0.63 mg | Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 3 (n=35,38,26) | 4.176 liters/second | Standard Deviation 0.966 |
| Levalbuterol 0.63 mg | Mean Peak Expiratory Flow Rate (PEFR) | 2 hours post dose 1 (n=36,37,27) | 4.221 liters/second | Standard Deviation 0.961 |
| Levalbuterol 0.63 mg | Mean Peak Expiratory Flow Rate (PEFR) | 4 hours post dose 1 (n=36,38,27) | 4.155 liters/second | Standard Deviation 0.984 |
| Levalbuterol 0.63 mg | Mean Peak Expiratory Flow Rate (PEFR) | 6 hours post dose 1 (n=36,38,27) | 3.970 liters/second | Standard Deviation 0.938 |
| Arformoterol 7.5 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 4 hours post dose 1 (n=36,38,27) | 4.029 liters/second | Standard Deviation 1.061 |
| Arformoterol 7.5 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | predose (n=37,38,27) | 3.546 liters/second | Standard Deviation 0.928 |
| Arformoterol 7.5 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 3 (n=34,38,27) | 4.003 liters/second | Standard Deviation 0.993 |
| Arformoterol 7.5 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 2 (n=36,38,27) | 3.964 liters/second | Standard Deviation 0.912 |
| Arformoterol 7.5 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 1 (n=37,38,27) | 3.788 liters/second | Standard Deviation 0.95 |
| Arformoterol 7.5 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 6 hours post dose 1 (n=36,38,27) | 4.058 liters/second | Standard Deviation 1.075 |
| Arformoterol 7.5 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 2 hours post dose 1 (n=36,37,27) | 4.178 liters/second | Standard Deviation 1.013 |
| Arformoterol 7.5 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 1 (n=37,37,27) | 3.877 liters/second | Standard Deviation 0.95 |
| Arformoterol 7.5 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 3 (n=35,38,26) | 4.007 liters/second | Standard Deviation 0.899 |
| Arformoterol 7.5 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 2 (n=36,38,27) | 3.890 liters/second | Standard Deviation 0.998 |
| Arformoterol 15 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 2 hours post dose 1 (n=36,37,27) | 4.066 liters/second | Standard Deviation 0.668 |
| Arformoterol 15 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 2 (n=36,38,27) | 3.925 liters/second | Standard Deviation 0.679 |
| Arformoterol 15 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 2 (n=36,38,27) | 3.989 liters/second | Standard Deviation 0.652 |
| Arformoterol 15 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 3 (n=34,38,27) | 4.077 liters/second | Standard Deviation 0.711 |
| Arformoterol 15 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 4 hours post dose 1 (n=36,38,27) | 4.039 liters/second | Standard Deviation 0.663 |
| Arformoterol 15 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 3 (n=35,38,26) | 4.017 liters/second | Standard Deviation 0.693 |
| Arformoterol 15 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | predose (n=37,38,27) | 3.565 liters/second | Standard Deviation 0.675 |
| Arformoterol 15 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 6 hours post dose 1 (n=36,38,27) | 4.016 liters/second | Standard Deviation 0.628 |
| Arformoterol 15 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 10 minutes post dose 1 (n=37,38,27) | 3.824 liters/second | Standard Deviation 0.613 |
| Arformoterol 15 Mcg | Mean Peak Expiratory Flow Rate (PEFR) | 25 minutes post dose 1 (n=37,37,27) | 3.844 liters/second | Standard Deviation 0.698 |
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.
Time frame: predose, various postdose times
Population: PK population consisted of subjects who were in the intent-to-treat population and had any plasma concentration data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Levalbuterol 0.63 mg | Plasma Concentration of (R,R) Formoterol | 2 hours post dose 1 (n=50,51,38) | 0 picogram/milliliter | Standard Deviation 0 |
| Levalbuterol 0.63 mg | Plasma Concentration of (R,R) Formoterol | 25 minutes post dose 2 (n=48,47,36) | 0 picogram/milliliter | Standard Deviation 0.8858 |
| Levalbuterol 0.63 mg | Plasma Concentration of (R,R) Formoterol | predose (n=51,52,39) | 0.646 picogram/milliliter | Standard Deviation 3.4172 |
| Levalbuterol 0.63 mg | Plasma Concentration of (R,R) Formoterol | 25 minutes post dose 1 (n=50,46,36) | 2.402 picogram/milliliter | Standard Deviation 15.1253 |
| Levalbuterol 0.63 mg | Plasma Concentration of (R,R) Formoterol | 6 hours post dose 1 (n=50,50,37) | 0 picogram/milliliter | Standard Deviation 0.8899 |
| Arformoterol 7.5 Mcg | Plasma Concentration of (R,R) Formoterol | 25 minutes post dose 2 (n=48,47,36) | 1.845 picogram/milliliter | Standard Deviation 2.8085 |
| Arformoterol 7.5 Mcg | Plasma Concentration of (R,R) Formoterol | predose (n=51,52,39) | 0 picogram/milliliter | Standard Deviation 0.5159 |
| Arformoterol 7.5 Mcg | Plasma Concentration of (R,R) Formoterol | 25 minutes post dose 1 (n=50,46,36) | 2.236 picogram/milliliter | Standard Deviation 13.0128 |
| Arformoterol 7.5 Mcg | Plasma Concentration of (R,R) Formoterol | 2 hours post dose 1 (n=50,51,38) | 1.885 picogram/milliliter | Standard Deviation 1.7035 |
| Arformoterol 7.5 Mcg | Plasma Concentration of (R,R) Formoterol | 6 hours post dose 1 (n=50,50,37) | 0.874 picogram/milliliter | Standard Deviation 1.1988 |
| Arformoterol 15 Mcg | Plasma Concentration of (R,R) Formoterol | 6 hours post dose 1 (n=50,50,37) | 2.818 picogram/milliliter | Standard Deviation 1.7195 |
| Arformoterol 15 Mcg | Plasma Concentration of (R,R) Formoterol | 2 hours post dose 1 (n=50,51,38) | 4.189 picogram/milliliter | Standard Deviation 2.8207 |
| Arformoterol 15 Mcg | Plasma Concentration of (R,R) Formoterol | predose (n=51,52,39) | 0.737 picogram/milliliter | Standard Deviation 2.7612 |
| Arformoterol 15 Mcg | Plasma Concentration of (R,R) Formoterol | 25 minutes post dose 2 (n=48,47,36) | 3.325 picogram/milliliter | Standard Deviation 2.3515 |
| Arformoterol 15 Mcg | Plasma Concentration of (R,R) Formoterol | 25 minutes post dose 1 (n=50,46,36) | 1.659 picogram/milliliter | Standard Deviation 2.4584 |