This study evaluates the long-term (24-week) safety and efficacy of GW815SF Salmeterol/fluticasone propionate(HFA MDI) 50/100mcg(administered as 2 inhalations of 25/50mcg) bid in pediatric patients with bronchial asthma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
GSK Clinical Trials Call Center
Funabashi, Chiba, Japan
GSK Clinical Trials Call Center
Setagaya, Tokyo, Japan
GSK Clinical Trials Call Center
Takasaki, Gunma, Japan
Most Frequent Adverse Events - On Therapy
Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.
Time frame: Baseline to Week 24
Serious Adverse Events (SAEs) - On Therapy
Number of participants considered by the investigator to be related to study medication. Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)
Time frame: Baseline to Week 24
Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24
PEF taken daily and average used for week 1-24 value. The peak expiratory flow rate measures how fast a person can (exhale) air. Then, compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Time frame: Baseline and during Weeks 1-24
Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24
Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning.
Time frame: Baseline and during Weeks 1-24
Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24
The peak expiratory flow rate measures how fast a person can (exhale) air. Then compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Time frame: Baseline and during Weeks 1-24
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Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24
Circadian Variation means the various changes in a day. The peak expiratory flow rate measures how fast a person can (exhale) air using a mini-Wright peak flow meter. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Time frame: Baseline and during Weeks 1-24
Number of Participants With Symptom-Free Nights and Days
Time frame: Baseline and Week 24
Number of Participants With Rescue Medication-Free Nights and Days
Rescue free means without the use of other medication.
Time frame: Baseline and Week 24