A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects
- Registration Number
- NCT00583947
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ARF/LEV arformoterol 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. ARF/LEV levalbuterol 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. LEV/ARF levalbuterol 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. LEV/ARF arformoterol 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.
- Primary Outcome Measures
Name Time Method 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
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 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.
- Secondary Outcome Measures
Name Time Method 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.
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.