To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma. To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in paediatric patients with asthma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
salmeterol and fluticasone propionate combination
salmeterol + fluticasone propionate
GSK Investigational Site
Chiba, Japan
GSK Investigational Site
Kanagawa, Japan
GSK Investigational Site
Saitama, Japan
GSK Investigational Site
Saitama, Japan
Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods
Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \[Weeks 1-4/Weeks 7-10\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period \[Weeks 1-4/Weeks 7-10\]).
Time frame: Crossover Period Weeks 1-4, and 7-10
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods
Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \[Weeks 1-4/Weeks 7-10\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.
Time frame: Crossover Period Weeks 1-4, 7-10
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods
Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \[Weeks 1-4/Weeks 7-10\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.
Time frame: Crossover Period weeks 1-4, 7-10
Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods
Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \[Weeks 1-4/Weeks 7-10\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.
Time frame: Crossover Period weeks 1-4, 7-10
Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods
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GSK Investigational Site
Tokyo, Japan
GSK Investigational Site
Tokyo, Japan
GSK Investigational Site
Tokyo, Japan
GSK Investigational Site
Tokyo, Japan
Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period \[Weeks 1-4/Weeks 7-10\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.
Time frame: Crossover Period Weeks 1-4, 7-10
Percentage of Subjects With Symptom-Free Nights & Days
Percentage of subjects with Symptom Free Nights \& Days after 4 weeks of Treatment
Time frame: Crossover Period Week 1-4, 7-10
Percentage of Subjects With Rescue Medication-Free Nights and Days
Percentage of subjects with Rescue Medication Free Nights \& Days after 4 weeks of Treatment
Time frame: Crossover Period Weeks 1-4, 7-10
Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period
Mean change from baseline = value at assessment period (mean of the values obtained at assessment period (Weeks 11-30).) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting of the Extension period (Weeks 11-30).
Time frame: Extension Period Weeks 11-30
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period
Mean change from baseline = value at assessment period (mean of the values obtained at assessment period \[Weeks 11-30\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).
Time frame: Extension Period weeks 11-30
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period
Mean change from baseline = value at assessment period (mean of the values obtained at assessment period \[Weeks 11-30\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).
Time frame: Extension Period weeks 11-30
Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period
Mean change from baseline = value at assessment period (mean of the values obtained at assessment period \[Weeks 11-30\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).
Time frame: Extension Period weeks 11-30
Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period
Mean change from baseline = value at assessment period (mean of the values obtained at assessment period \[Weeks 11-30\]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).
Time frame: Extension Period weeks 11-30
Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment
Percentage of subjects with Symptom Free Nights \& Days after 20 weeks of Treatment (at week 30).
Time frame: Extension Period Weeks 11-30
Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment
Percentage of subjects with Rescue Medication Free Nights \& Days after 20 weeks of Treatment (at week 30).
Time frame: Extension Period Weeks 11-30