CClinicalTrials.gg
Sign In
CompletedNCT00583947Updated Feb 22, 2012Results posted

A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects

A Phase 2 interventional study of arformoterol and levalbuterol in Asthma, sponsored by Sumitomo Pharma America, Inc.. Completed at 14 sites in United States. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2012-02-22.

Sponsored by Sumitomo Pharma America, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
2 Years to 11 Years
Sex
All
01

Study summary

To determine the safety and tolerability of Arformoterol Tartrate in children with asthma

Read the 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.

02

Conditions studied

  • Asthma

Browse trials for

Keywords

  • Asthma
  • Respiratory Tract Diseases
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 53 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Sumitomo Pharma America, Inc. is the lead sponsor of 176 studies on the registry; 5 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 20 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 11 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
53 participants (actual)

Study arms

  • Other
    ARF/LEV

    Cross-over phase: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization. Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.

    Drug: arformoterol · Drug: levalbuterol

  • Other
    LEV/ARF

    Cross-over phase: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization. Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.

    Drug: arformoterol · Drug: levalbuterol

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).

    Also known as: Brovana

  • 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).

    Also known as: Xopenex

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Mean Serum Potassium Levels

    Time frame: Predose, 2 hours and 6 hours postdose 1

  8. 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

  9. Mean Serum Glucose Values

    Time frame: Predose, 2 and 6 hours post dose 1

  10. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

07

Results

Posted Feb 8, 2010
Limitations and caveats
Sample size was determined outside of statistical considerations. All data recorded at/after Visit 8 for 6 subjects, misdosed with ARF 7.5mcg instead of ARF 15mcg in open-label period, were excluded from the planned efficacy, PK and safety analyses.

Participant flow

Cross-over Period
Participant flow — Cross-over Period
MilestoneARF/LEVLEV/ARF
Started2726
Completed2224
Not completed52
Withdrew: Adverse event20
Withdrew: Withdrawal by subject20
Withdrew: Did not meet-no longer met entry criteri01
Withdrew: Other11
Washout
Participant flow — Washout
MilestoneARF/LEVLEV/ARF
Started2224
Completed2224
Not completed00
Open Label Period
Participant flow — Open Label Period
MilestoneARF/LEVLEV/ARF
Started2224
Completed2224
Not completed00

Outcome measures

PrimaryMean 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
Reported as:
Mean · beats per minute
Mean Heart Rate
beats per minuteLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
Predose (n=51,52,40)87.6 ± 12.5684.7 ± 14.1187.0 ± 17.47
15 min post dose 1 (n=51,52,40)89.3 ± 15.5785.2 ± 15.1989.4 ± 16.88
30 min post dose 1 (n=51,52,40)90.9 ± 14.4786.6 ± 14.6389.5 ± 15.59
60 min post dose 1 (n=51,51,40)96.4 ± 12.3389.0 ± 13.6793.5 ± 16.41
15 min post dose 2 (n=50,51,40)95.4 ± 12.9487.5 ± 14.8892.5 ± 18.60
30 min post dose 2 (n=47,50,40)97.1 ± 13.2888.9 ± 13.3393.3 ± 16.72
60 min post dose 2 (n=46,50,37)100.4 ± 16.6089.3 ± 13.9796.1 ± 12.80
30 min post last dose (n=49,52,40)99.2 ± 17.3890.3 ± 14.2496.1 ± 13.92
60 min post last dose (n=49,52,40)96.0 ± 16.4593.3 ± 13.0697.1 ± 14.95
1.5 hours post last dose (n=48,52,40)96.2 ± 17.2991.8 ± 11.7595.3 ± 16.42
2 hours post last dose (n=50,52,40)93.0 ± 16.2391.2 ± 11.7795.9 ± 14.57
2.5 hours post last dose (n=49,52,40)94.1 ± 16.2290.2 ± 14.6194.8 ± 15.66
3 hours post last dose (n=50,52,40)94.1 ± 14.8490.6 ± 13.5793.4 ± 16.04
3.5 hours post last dose (n=50,52,40)93.3 ± 14.6589.8 ± 13.2095.0 ± 15.16
4 hours post last dose (n=50,52,40)94.0 ± 12.6889.3 ± 11.7694.5 ± 14.94
4.5 hours post last dose (n=50,52,40)93.3 ± 13.7189.6 ± 12.5093.9 ± 16.49
5 hours post last dose (n=50,51,40)92.4 ± 15.3689.8 ± 14.1692.9 ± 14.51
SecondaryMean 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
Reported as:
Mean · liters
Mean Forced Expiratory Volume in One Second(FEV1)
litersLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
predose (n=37,38,27)1.554 ± 0.3741.552 ± 0.3771.486 ± 0.294
10 minutes post dose 1 (n=37,38,27)1.714 ± 0.4111.668 ± 0.4031.620 ± 0.315
25 minutes post dose 1 (n=37,37,27)1.712 ± 0.4251.695 ± 0.4091.644 ± 0.334
10 minutes post dose 2 (n=36,38,27)1.741 ± 0.4301.721 ± 0.4201.661 ± 0.332
25 minutes post dose 2 (n=36,38,27)1.735 ± 0.4381.714 ± 0.4231.669 ± 0.331
10 minutes post dose 3 (n=34,38,27)1.775 ± 0.4021.731 ± 0.4191.689 ± 0.340
25 minutes post dose 3 (n=35,38,26)1.782 ± 0.4151.740 ± 0.4191.700 ± 0.345
2 hours post dose 1 (n=36,37,27)1.784 ± 0.3971.754 ± 0.4081.704 ± 0.337
4 hours post dose 1 (n=36,38,27)1.732 ± 0.4011.722 ± 0.4231.684 ± 0.344
6 hours post dose 1 (n=36,38,27)1.667 ± 0.4001.725 ± 0.4261.660 ± 0.356
PrimaryChange 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
Reported as:
Mean · beats per minute
Change From Predose in Mean Heart Rate
beats per minuteLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
15 min post dose 1 (n=51,52,40)1.6 ± 10.270.5 ± 9.402.3 ± 10.33
30 min post dose 1 (n=51,52,40)3.2 ± 11.912.0 ± 11.062.5 ± 11.14
60 min post dose 1 (n=51,51,40)8.7 ± 10.704.4 ± 11.856.5 ± 12.62
15 min post dose 2 (n=50,51,40)7.8 ± 10.722.8 ± 11.485.5 ± 12.89
30 min post dose 2 (n=47,50,40)10.0 ± 10.674.5 ± 10.466.3 ± 12.90
60 min post dose 2 (n=46,50,37)13.2 ± 13.814.7 ± 10.509.5 ± 12.89
30 min post last dose (n=49,52,40)11.9 ± 14.115.6 ± 11.449.0 ± 13.34
60 min post last dose (n=49,52,40)8.7 ± 13.978.6 ± 14.0610.0 ± 14.81
1.5 hours post last dose (n=48,52,40)8.9 ± 11.737.1 ± 12.658.3 ± 15.95
2 hours post last dose (n=50,52,40)5.6 ± 12.136.6 ± 10.778.9 ± 12.69
2.5 hours post last dose (n=49,52,40)6.8 ± 11.205.5 ± 14.337.8 ± 13.36
3 hours post last dose (n=50,52,40)6.7 ± 10.945.9 ± 12.746.4 ± 13.31
3.5 hours post last dose (n=50,52,40)5.9 ± 11.895.1 ± 11.637.9 ± 12.11
4 hours post last dose (n=50,52,40)6.6 ± 10.304.6 ± 13.517.4 ± 11.62
4.5 hours post last dose (n=50,52,40)5.9 ± 10.864.9 ± 12.006.9 ± 12.70
5 hours post last dose (n=50,51,40)5.0 ± 12.035.3 ± 12.415.8 ± 12.55
PrimaryMean 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
Reported as:
Mean · mmHg
Mean Systolic Blood Pressure
mmHgLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
Predose (n=51,52,40)102.1 ± 10.80101.5 ± 9.86100.6 ± 10.36
15 min post dose 1 (n=51,52,40)102.9 ± 10.90101.2 ± 11.07102.6 ± 11.42
30 min post dose 1 (n=51,52,40)104.6 ± 12.08102.5 ± 10.20100.3 ± 9.78
60 min post dose 1 (n=51,51,40)105.8 ± 9.31102.7 ± 9.82103.2 ± 10.82
15 min post dose 2 (n=50,51,40)105.0 ± 11.20101.7 ± 9.42102.1 ± 12.20
30 min post dose 2 (n=47,50,40)106.4 ± 10.32102.8 ± 9.26101.9 ± 9.81
60 min post dose 2 (n=46,50,37)107.2 ± 12.05101.9 ± 11.18102.9 ± 9.95
30 min post last dose (n=49,52,40)105.0 ± 12.22101.2 ± 11.72101.6 ± 12.60
60 min post last dose (n=49,52,40)106.1 ± 10.32103.0 ± 11.87104.9 ± 11.03
1.5 hours post last dose (n=48,52,40)104.8 ± 11.43101.9 ± 11.67103.0 ± 10.35
2 hours post last dose (n=50,52,40)104.6 ± 11.40103.4 ± 10.81101.8 ± 10.87
2.5 hours post last dose (n=49,52,40)103.0 ± 12.41101.5 ± 10.58101.3 ± 10.10
3 hours post last dose (n=50,52,40)106.1 ± 12.28102.1 ± 10.84101.9 ± 11.57
3.5 hours post last dose (n=50,52,40)103.4 ± 10.00103.2 ± 11.38101.4 ± 9.41
4 hours post last dose (n=50,52,40)103.6 ± 11.26102.1 ± 10.14100.5 ± 10.48
4.5 hours post last dose (n=50,52,40)104.5 ± 10.50103.2 ± 10.96101.5 ± 9.25
5 hours post last dose (n=50,52,40)106.7 ± 9.94104.1 ± 10.46102.1 ± 9.49
PrimaryChange 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
Reported as:
Mean · mmHg
Change From Predose in Mean Systolic Blood Pressure
mmHgLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
15 min post dose 1 (n=51,52,40)0.8 ± 10.58-0.4 ± 9.572.0 ± 8.06
30 min post dose 1 (n=51,52,40)2.6 ± 10.140.9 ± 6.97-0.3 ± 7.68
60 min post dose 1 (n=51,51,40)3.7 ± 8.601.1 ± 9.542.6 ± 7.97
15 min post dose 2 (n=50,51,40)2.6 ± 8.94-0.3 ± 9.281.6 ± 9.07
30 min post dose 2 (n=47,50,40)3.3 ± 8.590.8 ± 9.011.4 ± 7.19
60 min post dose 2 (n=46,50,37)4.0 ± 7.89-0.3 ± 8.981.8 ± 8.87
30 min post last dose (n=49,52,40)2.4 ± 10.72-0.4 ± 9.371.1 ± 11.25
60 min post last dose (n=49,52,40)3.5 ± 10.921.5 ± 11.174.4 ± 8.43
1.5 hours post last dose (n=48,52,40)1.8 ± 9.700.3 ± 10.222.4 ± 8.06
2 hours post last dose (n=50,52,40)2.3 ± 10.311.8 ± 10.181.3 ± 9.44
2.5 hours post last dose (n=49,52,40)0.4 ± 10.12-0.0 ± 8.800.7 ± 7.77
3 hours post last dose (n=50,52,40)3.9 ± 10.580.6 ± 8.831.3 ± 7.28
3.5 hours post last dose (n=50,52,40)1.2 ± 8.871.7 ± 10.180.9 ± 7.06
4 hours post last dose (n=50,52,40)1.3 ± 11.080.6 ± 10.17-0.0 ± 8.36
4.5 hours post last dose (n=50,52,40)2.2 ± 10.371.7 ± 9.610.9 ± 8.26
5 hours post last dose (n=50,52,40)4.5 ± 10.792.5 ± 8.901.6 ± 9.62
PrimaryMean 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
Reported as:
Mean · mmHg
Mean Diastolic Blood Pressure
mmHgLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
Predose (n=51,52,40)62.5 ± 8.1963.2 ± 6.8263.6 ± 9.77
15 min post dose 1 (n=51,52,40)61.4 ± 9.3262.0 ± 7.2962.5 ± 8.52
30 min post dose 1 (n=51,52,40)60.8 ± 8.3462.5 ± 7.6161.6 ± 7.56
60 min post dose 1 (n=51,51,40)63.4 ± 7.7262.5 ± 7.4762.3 ± 9.38
15 min post dose 2 (n=50,51,40)61.7 ± 8.7663.3 ± 6.7560.8 ± 8.81
30 min post dose 2 (n=47,50,40)63.1 ± 7.3562.2 ± 7.6161.7 ± 8.86
60 min post dose 2 (n=46,50,37)62.8 ± 8.0762.0 ± 8.1562.3 ± 7.99
30 min post last dose (n=49,52,40)63.4 ± 7.2762.0 ± 8.8361.6 ± 7.91
60 min post last dose (n=49,52,40)63.5 ± 8.8862.1 ± 8.6062.5 ± 8.09
1.5 hours post last dose (n=48,52,40)63.1 ± 9.0962.3 ± 7.9062.5 ± 9.03
2 hours post last dose (n=50,52,40)63.8 ± 10.7962.3 ± 6.8762.1 ± 9.62
2.5 hours post last dose (n=49,52,40)60.7 ± 10.4159.7 ± 7.9762.3 ± 8.71
3 hours post last dose (n=50,52,40)63.2 ± 8.8561.4 ± 7.5162.5 ± 9.77
3.5 hours post last dose (n=50,52,40)62.0 ± 9.8060.5 ± 6.5462.6 ± 7.59
4 hours post last dose (n=50,52,40)62.9 ± 10.1563.1 ± 7.3259.9 ± 8.65
4.5 hours post last dose (n=50,52,40)62.6 ± 9.1262.2 ± 7.8461.9 ± 8.38
5 hours post last dose (n=50,52,40)62.3 ± 8.7563.0 ± 7.4060.0 ± 8.59
PrimaryChange 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
Reported as:
Mean · mmHg
Change From Predose in Mean Diastolic Blood Pressure
mmHgLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
15 min post dose 1 (n=51,52,40)-1.1 ± 8.60-1.1 ± 7.26-1.0 ± 10.23
30 min post dose 1 (n=51,52,40)-1.7 ± 7.69-0.6 ± 7.84-1.9 ± 7.27
60 min post dose 1 (n=51,51,40)0.8 ± 7.89-0.7 ± 7.71-1.3 ± 9.43
15 min post dose 2 (n=50,51,40)-1.1 ± 8.100.1 ± 6.85-2.8 ± 9.65
30 min post dose 2 (n=47,50,40)0.8 ± 7.82-1.1 ± 7.59-1.9 ± 9.59
60 min post dose 2 (n=46,50,37)0.0 ± 7.08-1.3 ± 6.98-1.8 ± 6.91
30 min post last dose (n=49,52,40)0.8 ± 7.12-1.2 ± 7.34-1.9 ± 9.35
60 min post last dose (n=49,52,40)0.8 ± 8.84-1.1 ± 8.48-1.1 ± 8.31
1.5 hours post last dose (n=48,52,40)0.1 ± 8.00-0.9 ± 7.23-1.1 ± 9.38
2 hours post last dose (n=50,52,40)1.4 ± 10.16-0.9 ± 7.70-1.5 ± 9.39
2.5 hours post last dose (n=49,52,40)-1.9 ± 8.66-3.5 ± 7.36-1.3 ± 9.56
3 hours post last dose (n=50,52,40)0.8 ± 8.45-1.8 ± 8.31-1.1 ± 10.49
3.5 hours post last dose (n=50,52,40)-0.4 ± 8.36-2.6 ± 6.66-1.0 ± 8.87
4 hours post last dose (n=50,52,40)0.5 ± 10.38-0.0 ± 7.63-3.7 ± 10.29
4.5 hours post last dose (n=50,52,40)0.2 ± 8.86-1.0 ± 7.64-1.7 ± 10.42
5 hours post last dose (n=50,52,40)-0.1 ± 8.84-0.1 ± 8.06-3.6 ± 10.25
PrimaryMean Serum Potassium Levels
Time frame:
Predose, 2 hours and 6 hours postdose 1
Reported as:
Mean · mEq/L
Mean Serum Potassium Levels
mEq/LLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
Predose (n=51,52,39)4.25 ± 0.3764.27 ± 0.3864.31 ± 0.325
2 hours post dose 1 (n=48,47,38)3.67 ± 0.4233.83 ± 0.3913.71 ± 0.410
6 hours post dose 1 (n=48,49,38)3.99 ± 0.3343.95 ± 0.3253.87 ± 0.435
PrimaryChange 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
Reported as:
Mean · mEq/L
Change From Predose in Mean Serum Potassium
mEq/LLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
2 hours post dose 1 (n=48,47,38)-0.58 ± 0.457-0.42 ± 0.407-0.62 ± 0.401
6 hours post dose 1 (n=48,49,38)-0.23 ± 0.307-0.31 ± 0.450-0.39 ± 0.424
PrimaryMean Serum Glucose Values
Time frame:
Predose, 2 and 6 hours post dose 1
Reported as:
Mean · mg/dl
Mean Serum Glucose Values
mg/dlLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
Predose (n=51,52,40)86.4 ± 15.5987.5 ± 15.4387.6 ± 17.41
2 hours post dose 1 (n=48,47,39)114.5 ± 30.42108.6 ± 27.51120.6 ± 32.52
6 hours post dose 1 (n=49,48,38)107.6 ± 18.4399.0 ± 15.78106.3 ± 15.64
PrimaryChange 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
Reported as:
Mean · mg/dl
Change From Predose in Mean Serum Glucose
mg/dlLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
2 hours post dose 1 (n=48,47,39)27.1 ± 34.7422.4 ± 32.6632.9 ± 35.21
6 hours post dose 1 (n=49,48,38)20.3 ± 22.4912.1 ± 20.5918.6 ± 23.11
SecondaryChange 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
Reported as:
Mean · liters
Change From Predose of Mean Forced Expiratory Volume in One Second (FEV1)
litersLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
10 minutes post dose 1 (n=37,38,27)0.160 ± 0.1020.117 ± 0.1120.133 ± 0.105
25 minutes post dose 1 (n=37,37,27)0.159 ± 0.1390.142 ± 0.1510.158 ± 0.125
10 minutes post dose 2 (n=36,38,27)0.199 ± 0.1300.169 ± 0.1540.175 ± 0.106
25 minutes post dose 2 (n=36,38,27)0.194 ± 0.1530.162 ± 0.1660.183 ± 0.137
10 minutes post dose 3 (n=34,38,27)0.226 ± 0.1440.179 ± 0.1600.203 ± 0.148
25 minutes post dose 3 (n=35,38,26)0.226 ± 0.1540.188 ± 0.1500.205 ± 0.152
2 hours post dose 1 (n=36,37,27)0.216 ± 0.1390.194 ± 0.1460.218 ± 0.149
4 hours post dose 1 (n=36,38,27)0.163 ± 0.1500.170 ± 0.1750.198 ± 0.150
6 hours post dose 1 (n=36,38,27)0.098 ± 0.1280.173 ± 0.1650.174 ± 0.166
SecondaryMean 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
Reported as:
Mean · liters/second
Mean Peak Expiratory Flow Rate (PEFR)
liters/secondLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
predose (n=37,38,27)3.604 ± 0.9493.546 ± 0.9283.565 ± 0.675
10 minutes post dose 1 (n=37,38,27)3.926 ± 0.9003.788 ± 0.9503.824 ± 0.613
25 minutes post dose 1 (n=37,37,27)4.003 ± 0.8933.877 ± 0.9503.844 ± 0.698
10 minutes post dose 2 (n=36,38,27)4.053 ± 1.0073.890 ± 0.9983.925 ± 0.679
25 minutes post dose 2 (n=36,38,27)4.047 ± 0.9823.964 ± 0.9123.989 ± 0.652
10 minutes post dose 3 (n=34,38,27)4.156 ± 0.9604.003 ± 0.9934.077 ± 0.711
25 minutes post dose 3 (n=35,38,26)4.176 ± 0.9664.007 ± 0.8994.017 ± 0.693
2 hours post dose 1 (n=36,37,27)4.221 ± 0.9614.178 ± 1.0134.066 ± 0.668
4 hours post dose 1 (n=36,38,27)4.155 ± 0.9844.029 ± 1.0614.039 ± 0.663
6 hours post dose 1 (n=36,38,27)3.970 ± 0.9384.058 ± 1.0754.016 ± 0.628
SecondaryChange 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
Reported as:
Mean · liters/second
Change From Predose in Mean Peak Expiratory Flow Rate (PEFR)
liters/secondLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
10 minutes post dose 1 (n=37,38,27)0.322 ± 0.3050.242 ± 0.2980.259 ± 0.396
25 minutes post dose 1 (n=37,37,27)0.399 ± 0.3670.320 ± 0.3920.279 ± 0.442
10 minutes post dose 2 (n=36,38,27)0.458 ± 0.3630.344 ± 0.3690.360 ± 0.406
25 minutes post dose 2 (n=36,38,27)0.452 ± 0.3290.419 ± 0.3630.424 ± 0.383
10 minutes post dose 3 (n=34,38,27)0.524 ± 0.3430.457 ± 0.4390.513 ± 0.466
25 minutes post dose 3 (n=35,38,26)0.539 ± 0.3750.462 ± 0.4290.449 ± 0.497
2 hours post dose 1 (n=36,37,27)0.575 ± 0.3850.596 ± 0.5960.501 ± 0.408
4 hours post dose 1 (n=36,38,27)0.509 ± 0.3450.484 ± 0.4400.474 ± 0.449
6 hours post dose 1 (n=36,38,27)0.324 ± 0.3370.513 ± 0.7200.451 ± 0.462
SecondaryPlasma 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
Reported as:
Mean · picogram/milliliter
Plasma Concentration of (R,R) Formoterol
picogram/milliliterLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
predose (n=51,52,39)0.646 ± 3.41720 ± 0.51590.737 ± 2.7612
25 minutes post dose 1 (n=50,46,36)2.402 ± 15.12532.236 ± 13.01281.659 ± 2.4584
25 minutes post dose 2 (n=48,47,36)0 ± 0.88581.845 ± 2.80853.325 ± 2.3515
2 hours post dose 1 (n=50,51,38)0 ± 0.00001.885 ± 1.70354.189 ± 2.8207
6 hours post dose 1 (n=50,50,37)0 ± 0.88990.874 ± 1.19882.818 ± 1.7195

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Levalbuterol 0.63 mg—0/51 (0%)10/51 (19.6%)
Arformoterol 7.5 Mcg—0/52 (0%)7/52 (13.5%)
Arformoterol 15 Mcg—0/40 (0%)8/40 (20%)
Most frequent other events
Showing 10 of 25
Most frequent other events
EventLevalbuterol 0.63 mgArformoterol 7.5 McgArformoterol 15 Mcg
Urinary Tract InfectionInfections and infestations0/510/522/40
InfluenzaInfections and infestations2/510/520/40
NasopharyngitisInfections and infestations2/510/520/40
Abdominal Pain UpperGastrointestinal disorders0/511/521/40
ToothacheGastrointestinal disorders0/510/521/40
Otitis MediaInfections and infestations0/510/521/40
HyperglycaemiaMetabolism and nutrition disorders0/510/521/40
ArthralgiaMusculoskeletal and connective tissue disorders0/510/521/40
HeadacheNervous system disorders0/510/521/40
RhinorrhoeaRespiratory, thoracic and mediastinal disorders0/510/521/40

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)ARF/LEVLEV/ARFTotal
<=18 years272653
Between 18 and 65 years000
>=65 years000
Age Continuous
Age Continuous(years)ARF/LEVLEV/ARFTotal
Age 2-5 years4.4 ± 0.794.4 ± 0.794.4 ± 0.76
Age 6-11 years9.0 ± 1.268.5 ± 1.438.8 ± 1.35
Sex: Female, Male
Sex: Female, Male(Participants)ARF/LEVLEV/ARFTotal
Female131225
Male141428
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)ARF/LEVLEV/ARFTotal
White/Caucasian191231
Black/African American61420
Other202
Region of Enrollment
Region of Enrollment(participants)ARF/LEVLEV/ARFTotal
United States272653
Height
Height(centimeters)ARF/LEVLEV/ARFTotal
Mean131.62 ± 15.244130.42 ± 15.377131.03 ± 15.174
Weight
Weight(kilograms)ARF/LEVLEV/ARFTotal
Mean31.57 ± 12.10632.68 ± 12.80232.12 ± 12.345
08

Study locations

14 sites
  • Beverly Hills, California 90211, United States
  • Orange, California 92868, United States
  • Savannah, Georgia 31406, United States
  • Normal, Illinois 61761, United States
  • Oklahoma City, Oklahoma 73112, United States
  • Oklahoma City, Oklahoma 73120, United States
  • Medford, Oregon 97504, United States
  • Portland, Oregon 97213, United States
  • Upland, Pennsylvania 19013, United States
  • Orangeburg, South Carolina 29118, United States
  • Spartanburg, South Carolina 29303, United States
  • Dallas, Texas 75230, United States
  • Burke, Virginia 22015, United States
  • Richmond, Virginia 23229, United States
09

References and documents

Publications

  • Hinkle J, Hinson J, Kerwin E, Goodwin E, Sciarappa K, Curry L, Hanrahan JP. A cumulative dose, safety and tolerability study of arformoterol in pediatric subjects with stable asthma. Pediatr Pulmonol. 2011 Aug;46(8):761-9. doi: 10.1002/ppul.21446. Epub 2011 May 16. PubMed 21584948 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00583947
Lead sponsor
Sumitomo Pharma America, Inc.
Responsible party
Sponsor
First posted
Jan 2, 2008
Start date
Jan 2008
Primary completion
Dec 2008
Completion
Dec 2008
Results posted
Feb 8, 2010
Last update
Feb 22, 2012

Study contacts

Pulmonary Medical Director
study chair · Unicorn Pharma Consulting

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Asthma→

Other studies from this sponsor

Sumitomo Pharma America, Inc.

Start the discussion